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Inclusion Criteria: * Non-smoking, healthy male or female subject between 18 and 55 years of age, inclusive (Parts A-E); male or female subject between 18 and 70 years of age, inclusive (Parts F, G) * Body mass index (BMI) from 19 to 35 kg/m2, inclusive (Parts A-E); BMI ≥ 30 kg/m2 and ≤ 50 kg/m2 (Parts F, G) * Estimated glomerular filtration rate (eGFR) ≥ 80 mL/min (Parts A-E); eGFR ≥ 60 mL/min/1.73m2 or eGFR ≥ 45 mL/min/1.73m2, depending on cohort (Parts F, G) * ALT/AST/ALP ≤ 1 x ULN (Parts A-E); ALT/AST \< 3 x ULN, ALP \< 1.5 x ULN (Parts F, G) * Screening laboratory evaluations (hematology, chemistry, and urinalysis) must fall within the normal range of the local laboratory's reference ranges unless the results have been determined by the investigator to have no clinical significance (Parts A-E) * Subject must have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the investigator * Females of childbearing potential must have a negative pregnancy test at Screening and clinic admission * Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception * Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs Exclusion Criteria: * Pregnant or lactating subjects * Unstable type 2 diabetes (as defined as: HbA1c \> 10.0%; treatment with insulin and/or pioglitazone within 90 days prior to Screening; any history of diabetic ketoacidosis, hyperosmolar state, and/or acutely decompensated blood glucose control; hypoglycemia unawareness, hospitalization due to hypoglycemia, or history of severe hypoglycemia \[requiring outside assistance to regain normal neurologic status\]) (Part F) * History of type 2 diabetes diagnosed prior * Medical history of type 1 diabetes or latent autoimmune diabetes of adults (LADA) * Obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome) * Known serious hypersensitivity to tirzepatide or any of the excipients in tirzepatide (Part G) * Subjects who have any serious or active medical or psychiatric illness (including depression) that, in the opinion of the investigator, would interfere with the subject's treatment, assessment, or compliance with the protocol * Subjects who have received any investigational compound within 30 days or 5 half-lives, whichever is longer, prior to study drug dosing * Current alcohol abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety * Current substance abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety * A positive test result for human immunodeficiency virus (HIV-1) antibody, hepatitis B (HBV) surface antigen, or hepatitis C (HCV) antibody * Medical history of drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity) * Presence or history of cardiovascular disease, including significant cardiovascular disease (including a history of myocardial infarction based on ECG and/or clinical history), history of cardiac conduction abnormalities (including any history of ventricular tachycardia), congestive heart failure, cardiomyopathy with left ventricular ejection fraction \< 40%, a family history of Long QT Syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years * Syncope, palpitations, or unexplained dizziness * Implanted defibrillator or pacemaker * Medical history of liver disease, including but not limited to alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency) * Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions * History of medical or surgical treatment that permanently alters intestinal absorption (e.g., gastric or intestinal surgery) * Subjects who have received vaccination for COVID-19 within 14 days of Admission Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion Criteria: * Prescribed use of 1 or more antihypertensive medications * English-speaking * Residence in a disadvantaged neighborhood Exclusion Criteria: * History of malignant HTN * Inability to comprehend the study protocol * Institutionalized status * Significant sensory or neurocognitive deficit

Inclusion Criteria: * Area of healthy, free, and mobile conjunctiva in the target area in the study eye, i.e., superior bulbar conjunctiva. * Visible trabecular meshwork with Shaffer angle grade =\> 3 in the study eye at the Screening Visit. * IOP =\> 20 mm Hg and \<= 44 mm Hg for the study eye, measured by Goldmann applanation tonometer, at the Screening Visit and Baseline Visit. Exclusion Criteria: * Active neovascular, uveitic, or angle-recession glaucoma or any glaucoma-associated vascular disorders within 6 months of the Screening Visit in the study eye. * Prior XEN45, transscleral cycloablative procedures (such as cyclophotocoagulation, micropulse cyclophotocoagulation, cryotherapy, ultrasonic circular cyclocoagulation \[UC3\], etc.) or prior major conjunctival surgery (i.e., scleral buckle) in the study eye.

Inclusion Criteria: * Age 18-65 * Body mass index (BMI) greater than or equal to 27 kg/m\^2 * HgA1C greater than or equal to 5.7 percent or fasting glucose greater than or equal to 100mg/dL within the previous 6 months * Low-income as defined by having a family income at or below 400 percent of the federal poverty level guidelines for 2022 Exclusion Criteria: * Current use of antihyperglycemic agents (other than metformin) or approved anti- obesity medications or plans to start such regimens over the 3 months post-study enrollment * HbA1c greater than or equal to 10 percent * Plans to pursue bariatric surgery over the 6 months post-study enrollment * Weight loss of greater than 5 kg within the previous 3 months * Current active eating disorder, with the exception of binge eating disorder * Severe active psychiatric disease or significant cognitive impairment deemed by investigator likely to impede adherence to piloted intervention * Active illicit substance abuse * Pregnant, breastfeeding, or considering pregnancy within the next 6 months * Current participation in another clinical research trial deemed by investigator to conflict with current study

Inclusion Criteria: * Women of all racial and ethnic groups 18 years of age or older * Women with a diagnosis of invasive breast cancer (stages I-III) within the past 7 years * Women who have completed active treatment for breast cancer (surgery, chemotherapy, HER2-directed therapy and radiation) * Prior participation on clinical trials is allowed Exclusion Criteria: * Current receipt of interventional clinical trial participation * Stage IV (metastatic) cancer * Prior history of recurrence (except recurrence following ductal carcinoma in situ) * Inability to give informed consent * Unable to speak English, Spanish, Chinese, or Korean

Inclusion Criteria: * Age 18 years or older * Histologic diagnosis of invasive breast cancer (cytologic or histologic confirmation of nodal metastasis is sufficient to establish this eligibility criteria). * Clinical and/or pathologic stage T3-T4c OR N1-N3; for the IBC pilot cohort only, the stage requirement is T4d, any N, M1 * Mastectomy is the planned oncologic surgery but has not yet been performed at the time of protocol enrollment * Autologous (i.e. tissue-based) reconstruction is planned with either a free or rotational flap. * For patients with HER2 positive, non-IBC breast cancer treated with neoadjuvant chemotherapy, one of the following criteria must be met: 1. Residual invasive disease should be documented in either the breast or a regional nodal metastasis after neoadjuvant chemotherapy. This specific eligibility criteria can be satisfied by the post-chemotherapy standard of care breast biopsy. For this matter, the patient may be enrolled on the trial prior to biopsy. If the biopsy does not show residual invasive disease, then the patient will not proceed with protocol-directed therapy and will be removed and replaced from the study. 2. Medical oncologist has documented a discussion in the chart about potential risks of proceeding with PreMRT with regard to impact on adjuvant systemic therapy decisions and the patient has opted to proceed with trial enrollment * For T4d pilot cohort patients, post-chemotherapy, pre-radiation ultrasound must demonstrate at least partial response in the breast and regional lymph nodes and no suspicious infraclavicular, internal mammary, and supraclavicular lymph nodes. * Ability to provide written informed consent in accordance with institutional policies. Exclusion Criteria: * Patients undergoing treatment for recurrent breast cancer in the index breast or lymph nodes. * History of therapeutic irradiation to the breast, lower neck, mediastinum or other area(s) that will overlap with the affected breast. * Presence of active scleroderma * Patients who are pregnant.

Inclusion Criteria: * Signed informed consent ; * Histologically confirmed diagnosis of invasive breast cancer; * Disease stage cT2-cT4, cN0-cN3, cM0; * Positive HER2 expression, negative estrogen and progesterone receptor expression; * ECOG score 0-1; * Adequate organ function; * Baseline LVEF ≥ 55%, as measured with the standard procedure; * Consent of women of childbearing potential to use highly effective methods of contraception, starting from the signing of the informed consent form, throughout the study and for 6 months after receiving the last dose of the product. Exclusion Criteria: * Stage IV (metastatic) breast cancer; * A history of any systemic therapy for breast cancer; * Concomitant diseases and/or conditions that significantly increase the risk of adverse events during the study; * Pregnancy or breastfeeding, as well as pregnancy planning throughout the study and for 6 months after receiving the last dose of the product; * Hypersensitivity or allergy to any of the components of BCD-178, Perjeta, trastuzumab, carboplatin, and docetaxel.

Key Inclusion Criteria: Clinical history of T1D with greater than or equal to (\>=) 5 years duration Participant is on a stable diabetic treatment Consistent use of continuous glucose monitoring (CGM) for at least 4 weeks before Screening and willingness to use CGM for the duration of the study Key Exclusion Criteria: Prior islet cell transplant, organ transplant, or cell therapy

Inclusion Criteria: * Aged ≥18 and older * Confirmed diagnosis of hormone receptor-positive breast cancer. * Subjects with locoregionally recurrent or metastatic disease not amenable to curative therapy. * Subjects have received or plan to receive CDK4/6 inhibitors for advanced disease. * ECOG 0-2 * Adequate organ function Exclusion Criteria: * Subjects disable to swallow pills. * History of immunodeficiency disease

Inclusion Criteria: * Resides in United States Exclusion Criteria: * Any individual who endorses any of the following criteria will be excluded from participation in this study: * Positive Health Screening Questions, as measured by the Health Screening Questionnaire (HSQ): * Pain, discomfort or pressure in the chest, difficulty breathing or shortness of breath, dizziness, fainting, or blackout, blood pressure with systolic greater than 140 or diastolic greater than 90, diagnosed or treated for any heart disease, heart murmur, chest pain (angina), palpitations (irregular beat), or heart attack, heart surgery, angioplasty, or a pacemaker, valve replacement, or heart transplant, resting pulse greater than 100 beats per minute, any arthritis, back trouble, hip /knee/joint /pain, or any other bone or joint condition, personal experience or doctor's advice of any other medical or physical reason that would prohibit the participant from doing light to moderate physical exercise, personal physician's recommendation against participating in light to moderate physical exercise because of asthma, diabetes, epilepsy or elevated cholesterol or a hernia. * Positive Psychiatric Disorders Screening Questions: * Positive screen for depression, excluding suicide (PHQ-8) cutoff score \> 6 * Positive screen for panic (SMPD) cutoff score \> 2 * Positive screen for generalized anxiety (GAD-7) cutoff score \> 10 * Positive screen psychosis (PDSQ) via psychosis section, cutoff score \> 3 * Positive screen mania via the Altman Self-Rating Mania Scale (ASRM) cutoff score \> 6

Inclusion Criteria: * Documented breast cancer and scheduled to receive adjuvant or neoadjuvant chemotherapy * Age \>= 21 years old * Diagnosed with solid tumor (e.g., head and neck, thoracic, or breast cancer) * Scheduled to receive at least one dose of chemotherapy or immunotherapy or radiation * Treated at Roswell Park Comprehensive Cancer Center Exclusion Criteria: * Presence of oral mucosal disease including oral mucositis, or oral candidiasis detected at baseline * Have uncontrolled intercurrent illness including, but not limited to, ongoing or active respiratory infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, heart failure or psychiatric illness/social situations that would limit compliance with study requirements * Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study intervention

Inclusion Criteria: * Children displaying elevated symptoms of internalizing or/and externalizing problems Exclusion Criteria: * Child is referred to or receives ongoing help in the specialized mental health services for problems in the internalizing or externalizing domains * Child is diagnosed with psychosis, mental retardation or pervasive developmental disorder * Acute suicide risk * Documented or probable ongoing physical or sexual abuse * Child or caretakers receives other systematic interventions targeting internalizing or externalizing problems while enrolled in the study (prior to 6 month follow-up)

Inclusion Criteria: 1. Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent; 2. Patients ≥18 years old; 3. Histologically confirmed metastatic breast cancer; 4. Histologically confirmed HER2 positive breast cancer, with HER2 positive defined by in situ hybridization (ISH), immunohistochemistry (IHC), or fluorescence in situ hybridization (FISH) methodology; Note: HER2 testing should be performed preferably metastatic site; any estrogen and progesterone (ER/PR) status is allowed; 5. Proven leptomeningeal progression defined by linear leptomeningeal metastases on magnetic resonance imaging (MRI) or the presence of breast cancer cells in CSF (obtained within 28 days before inclusion ); 6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2; 7. Life expectancy ≥2 months; 8. Stable dose of steroids for at least 5 days prior to registration; 9. If symptomatic brain or leptomeningeal metastasis, local treatment (surgery, radiation therapy) is allowed until 2 weeks before inclusion but should have been completed no more than 8 weeks before inclusion and with no clinical indication for immediate re-treatment with local therapy in the opinion of the investigator; 10. Adequate hematological function within 14 days before inclusion: Absolute neutrophil count (ANC) ≥1.5 x 10⁹/L; platelets count ≥100 x 10⁹/L; and hemoglobin ≥9.0 g/dL; 11. Adequate liver function within 14 days before inclusion: total bilirubin ≤1.5 ULN (unless documented Gilbert's syndrome); AST and ALT ≤2.5 ULN (≤5 ULN in the presence of liver metastases); 12. Normal renal function within 14 days before inclusion: estimated creatinine clearance ≥60 mL/min according to the Cockcroft-Gault formula; 13. Adequate cardiac function: * 12 Lead electrocardiograms (ECG) with normal tracing or non-clinically significant changes that do not require medical intervention * QT/QTc interval ≤470 msec for woman and ≤450 msec for men (mean of replicate values, correction per institutional standard) on the ECG at the screening visit and a normal kaliemia * Left ventricular ejection fraction (LVEF) ≥55% * No history of Torsades de Pointes or other symptomatic QTc abnormality 14. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to National cancer institute-Common terminology criteria for adverse events (NCI-CTCAE) version 5.0 grade 1 or 0 to baseline (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion); 15. Women of childbearing potential must have a negative pregnancy test (blood or urine test) within 14 days prior to inclusion; 16. Woman of childbearing potential and male patients must agree to use adequate contraception for the duration of trial participation and up to 7 months after completing treatment/therapy. Hormonal contraceptives such as birth control pills, patches, implants, or injections are not allowed in patients who are hormone receptor positive; 17. Patients affiliated to the social security system (or equivalent); 18. Patient must be willing and able to comply with the protocol for the duration of the trial including scheduled visits, treatment plan, laboratory tests, and examinations including follow-up. Exclusion Criteria: 1. Used of a strong cytochrome P450 (CYP)2C8 inhibitor within 5 half-lives of the inhibitor, or use of a strong CYP3A4 or CYP2C8 inducer within 5 days prior to first dose of study treatment. Use of sensitive CYP3A substrates should be avoided one week before enrollment and during study treatment; 2. Previous treatment with Tucatinib or Capecitabine; 3. Severe leukopenia, neutropenia, or thrombocytopena, severe hepatic impairment, severe renal impairment (creatinine clearance below 30mL/min) 4. Recent or concomitant treatment with brivudine ; 5. Any antiplatelet or curative anticoagulant treatment for blood coagulation disorders; 6. Severe pre-existing cerebrovascular dysfunction or pathology such as stroke and intra-cerebral hematoma or uncontrolled intracerebral hypertension induced by brain metastasis; 7. Ventriculoperitoneal or atrial shunt, except if the valve is equipped with an on-off device and that the patient's condition allows for to remain in the off position for 6 hours after each injection of trastuzumab; 8. Known history of testing positive for HIV or known acquired immunodeficiency syndrome; 9. Carriers of Hepatitis B or Hepatitis C or have other known chronic liver disease; 10. Uncontrolled hypertension; 11. Uncontrolled infection; 12. Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy; 13. Pregnant or breast-feeding women; 14. Known prior severe hypersensitivity to tucatinib or compounds chemically or/and biologically similar or any component in its formulation; 15. Hypersensitivity to trastuzumab, murine proteins, or to any of the excipients in its formulation; 16. Known prior severe hypersensitivity to capecitabine or to any of the excipients or fluorouracil; 17. Known complete dihydropyrimidine dehydrogenase (DPD) deficiency (if applicable); 18. Inability to swallow tablets or significant gastrointestinal disease which would preclude the adequate oral absorption of medications; 19. Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 5 years; 20. Person deprived of their liberty or under protective custody or guardianship; 21. Participation in another therapeutic trial within the 30 days prior to treatment initiation; 22. Patients with any other disease or illness, which requires hospitalization or is incompatible with the trial treatment, are not eligible. Patients unwilling or unable to comply with trial obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the trial.

Inclusion Criteria: * Female patients who are age 18 years and older * Patients must have a history of biopsy-proven Ductal carcinoma in situ (DCIS) or Stage I-III breast cancer and must be currently undergoing treatment or have completed primary treatment. * Patients must be found to have a vaginal health index (VHI) score of \<15. * Patients may be currently using endocrine therapy (ovarian function suppression, tamoxifen, or aromatase inhibitors). Patients not currently using endocrine therapy will also be eligible for participation since patients more than 5 or 10 years from diagnosis (and therefore having completed adjuvant endocrine therapy) may be enrolled. * Some patients with triple negative breast cancer who receive chemotherapy also experience GSM related to ovarian function decline outside of the setting of ovarian suppression, and therefore patients with either ER+ or ER- breast cancer will be allowed to participate. * Patients must provide written informed consent for participation in this study. * Patients are allowed to have used non-hormonal moisturizers but if they have previously used hormonal moisturizers, they will be asked to stop the use for one month prior to the first planned treatment, termed the "washout period", if needed. Exclusion Criteria: * Patients with any systemic or topical hormone replacement therapy within 3 months prior to enrollment, known genital infection, coagulation disorders, or on anticoagulant therapy or turmeric-containing supplements within the prior 2 weeks will be excluded. * Women who are pregnant or who plan to become pregnant within the following six months will be excluded since the impact of recent PRP injections to the vulva and the impact on obstetric injury during vaginal delivery has not been studied.

Inclusion Criteria: 1. female patients, age≥18 year 2. A score of ≥ 2 on the Eastern Cooperative Oncology Group scale 3. Patients pathologically diagnosed with untreated breast cancer by core-needle biopsy, with histologically confirmed non-palpable in situ cancer, including pleomorphic lobular carcinoma in situ or invasive non-palpable breast cancer that required localization 4. Patients are willing to undergo breast conserving surgery and have no contraindications to breast conserving surgery. Exclusion criteria: 1. Inflammatory breast cancer or Paget's disease 2. Breast deformities and other conditions that impact breast conservation success rate 3. Patients with contraindications to breast-conserving surgery, as well as those with systemic diseases, mental disorders, or other subjective reasons that may affect their ability to participate in the trial. Patients with severe bleeding disorders or coagulation disorders were also excluded 4. Pregnancy or lactation 5. Patients with hookwire, radioactive 125I seed or other localization techniques in the breast cancer lesions before enrollment 6. Patients with stage IV diseases or unresectable lesions in either breast 7. Patients combined with other diseases that may affect survival 8. Patients with multicentric breast cancer lesions or lesions \> 5 cm in diameter on imaging examinations 9. Patients who have previously undergone radical mastectomy for ipsilateral breast cancer or chest wall radiotherapy

Inclusion Criteria: * HbA1c \> 48 mmol/mol (with or without medical treatment); * less than 6 years since the diagnosis of T2D * BMI ≥ 27 kg/m2 (≥ 25 kg/m2 for Asians). Exclusion Criteria: * Insulin deficiency. * HbA1c concentration of 12% or more (≥108 mmol/mol), * treatment with sulphonyl urea or sodium-glucose-cotrasporter2-inhibitor (SGL2-i), * myocardial infarction within the previous 6 months, * severe or unstable heart failure * other severe diseases including cancer, psychiatric/eating disorders, severe depression - substance abuse, * conditions that may affect the ability of patients to participate in the study

Inclusion Criteria: * Patients with mood disorders (such as depression, bipolar disorder) diagnosed by a psychiatrist. * Patient Health Questionnaire-9 items (PHQ-9) score 5-19 points (indicating mild depression to moderate to severe depression) * Agree to participate in logotherapy * Able to participate in logotherapy Exclusion Criteria: * Patients with severe emotional disorders who cannot participate in logotherapy. * Those who have severe psychopathological phenomena and cannot judge reality or those who are mentally deficient. * Those who have serious suicidal ideation or clear suicide plan are not suitable for interview

Inclusion Criteria: * Age: 18 to 65 years * Patients with treatment-resistant MDD who have not responded to at least 2 and no more than 5 antidepressant trials of at least 8 weeks duration during the current episode and have been on a current stable antidepressant regiment for at least 4 weeks. The diagnosis of MDD will be confirmed using the MINI and the historical failure to respond to antidepressant therapy will be documented using the Antidepressant Treatment Response Questionnaire (ATRQ), with failure to respond defined as less than 50% improvement by subject history. * hs-CRP ≥ 3 mg/L and ≤ 10 mg/L * BMI \>25 kg/m2 and ≤ 40 kg/m2 * 17-item Hamilton Depression Rating Scale (HAM-D) score ≥15, and \<25% decrease in score between screen and baseline Exclusion Criteria: Diagnostic Exclusions: * Meeting lifetime DSM-5 criteria for: a neurocognitive disorder, psychotic disorder, bipolar disorder, obsessive compulsive disorder, bulimia nervosa, or anorexia nervosa in the 3 months prior to the screening; any substance use disorder (except for nicotine or caffeine use disorder). * Patients who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk * Presence of a serious or unstable medical illness, including insulin-dependent diabetes mellitus or bleeding disorder which, in the investigator's opinion, could compromise response to treatment, participant safety, or interpretation of study results. * Currently breastfeeding, pregnant women, or women of childbearing ability, who do NOT agree to use a study approved method of birth control (described in the MOP) for the duration of the study. * Currently or within 90 days of screen participating in another clinical trial (excluding large natural cohort trials such as 'All of Us'). Treatment and Concomitant Medication Exclusions: * Failure to respond during the course of the current major depressive episode to \>5 adequate antidepressant trials * Current use of antipsychotic medications or lithium * Having received ketamine therapy within 90 days of the screening visit * Patients who have initiated psychotherapy ≤ 90 days prior to screening.Having received electroconvulsive therapy during the current depressive episode or within 6 months of the screening visit * Concomitant use of any psychotropic agents within 2 weeks of the baseline visit, except for the ongoing antidepressant, prescription hypnotics, diphenhydramine, or a stable daily dose of a benzodiazepine. * Concomitant medications that might confound the biomarker findings within 1 week of the baseline visit and during the trial, including: regular (i.e. more than three times per week) ingestion of non-steroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase (COX)-2 inhibitors; any use of oral steroids, immunosuppressants, interferon, chemotherapy, or anticoagulants. Omega-3 Exclusions: * A history of severe sensitivity to soy products, fish products, or PUFA supplements * Patients who had taken supplements enriched with n-3 fatty acids within 60 days of the screening visit or who, at baseline, were consuming a diet containing \> 3 g/day of n-3 fatty acids, or who consume \> 2 meals of fatty fish per week. * Having taken a supplement of ≥1 g/day of n-3 fatty acids for ≥6 weeks during the current major depressive episode * Patients who have had either a poor response or intolerable side effects from n-3s in the past. * Patients with the following conditions: - Patients with the following conditions: history of atrial fibrillation or atrial flutter, left ventricle hypertrophy, stroke, cardiovascular disease (including coronary artery disease, heart failure, and moderate or severe valve disease or prior valve procedure), uncontrolled hypertension, Crohn's disease, Irritable Bowel Syndrome-diarrhea type, history of gastric bypass surgery, history of cholecystectomy, recent/current history of bulimia with purging, use of prokinetic medications that affect GI transit time, and small intestinal bacterial overgrowth (SIBO) * Sustained atrial fibrillation or atrial flutter of greater than 30 seconds detected by Holter monitor between V1 (screen) and V2 (baseline)

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of TNBC or HER2+BC per ASCO/CAP guidelines . A tumor can be considered a TNBC if the ER or PR is \<10%. * Trial participants must have a diagnosis of LMD. They must have the presence of malignant cells in the CSF (CSF+; note now cytology is considered diagnostic of LMD if the cytology is read as positive or suspicious; OR characteristic radiographic abnormalities (see below) of LMD). Signs and symptoms of LMD in and of themselves are not sufficient for inclusion. * Patients must have an Eastern Cooperative Oncology Group performance scale of ≤ 3. * Coincident Brain or Spinal cord metastases are allowed if these are stable and do not require local therapy at the time of enrollment. Individuals with previously treated stable Brain metastases are eligible to participate. * Stereotactic Radiosurgery (SRS) and/or prior radiotherapy is permitted \> 2 weeks prior to initial Dendritic Cell (DC) vaccine dose. A follow up brain MRI should be obtained prior to DC vaccine to determine stability of the lesions. An interval of at least 4 weeks after the end of whole brain radiation or for any surgical resection of brain lesions is permitted. * Life expectancy of ≥ 8 weeks. * Demonstrate adequate organ function as defined in protocol. All screening labs should be performed with 14 days of treatment initiation. * Provision of signed and dated informed consent form. * Corticosteroids at doses equivalent to 8 mg dexamethasone daily for symptom control are acceptable. This should be minimized wherever possible. * If the disease has progressed on current treatment in the CNS prior to consent, patients may continue current systemic cancer therapies as per PI discretion (Systemic Therapies Allowed) and Exclusion Criteria. Patients should not start a new anti-cancer agent until the 28 day safety period is completed. * Patients with systemic disease are eligible and will be managed as detailed in Section 6.3.1. * Pregnancy test: negative serum or urine pregnancy test at screening for women of childbearing potential. Must be repeated once-monthly during treatment. Contraception: Highly effective contraception for both male and female subjects throughout the study and for at least 90 days after last treatment administration, if the risk of conception exists. * The patient has an Ommaya reservoir or equivalent device which allows routine access to CSF and administration of DC1s. Exclusion Criteria: * Receiving other treatments specifically administered to treat LMD within the last 2 weeks or 5 half-lives of the agent, whichever is less. However, all other treatments to control systemic disease or bulk CNS disease will be eligible, provided the therapy is not a phase I agent, an agent which significantly and unequivocally penetrates the CSF (e.g., high-dose methotrexate, thiotepa, high-dose ara-C) per PI discretion. * The use of any immunotherapy within the last four weeks. * Patients with a ventriculoperitoneal or ventriculoatrial shunt must have an on/off device in their shunt systems to be eligible for the study. Patients must be able to tolerate shunt closure for \~4 hours without development of clinical signs of increased intracranial pressure. Patients unable to tolerate shunt closure for \~4 hours will not be eligible for the study. * Unable or unwilling to have a contrast-enhanced brain MRI. * Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin,squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. * Has an active infection requiring systemic therapy which in the opinion of the investigator will increase the risk to the patient. * Had major surgical procedure, or significant traumatic injury within two weeks. Ommaya placement is allowed. * Has a history of current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 90 days after the last dose of trial treatment. * Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1, 2 antibodies). Testing is not mandatory. * Has known active or chronic hepatitis B (HBV) or hepatitis C virus (HCV). Testing is not mandatory. * ORGAN TRANSPLANTATION: Prior organ transplantation including allogenic stem-cell transplantation. * Other severe acute or chronic medical conditions or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. * Has received a blood transfusion in the two weeks prior to leukapheresis. * Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Current COVID vaccines are not live vaccines.

Inclusion Criteria: * Subjects ≥18 years of age at the time of signing informed consent * Histologically or cytologically documented locally advanced or metastatic NSCLC, SCCHN, CRC, RCC, SCLC, PDAC, TNBC * Progressed or was intolerant to all available therapies known to confer clinical benefit appropriate for the tumor type * Adequate organ function * At least 1 measurable lesion per RECIST 1.1 Exclusion Criteria: * Treatment with anti-cancer therapy within 28 days or ≤5 elimination half-lives, whichever is earlier, before enrollment * Prior treatment with EGFR-targeted bispecific T cell engager or CAR-T cell therapy * Prior treatment with CD3 engaging bispecific antibodies * Clinically significant cardiovascular diseases * Active clinically significant infection (bacterial, viral, fungal, mycobacteria, or other) * On supplemental oxygen * Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment