Recruiting
Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
This Phase 1, multi-center, open-label, dose escalation and dose optimization study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and preliminary clinical activity of MOMA-313 administered orally as a single agent or combination therapy in patients with homologous recombinant deficient solid tumors.
ClinicalTrials.gov IDNCT06545942
PhasePHASE1
Enrollment220
SponsorMOMA Therapeutics
Age18 Years
SexALL
Conditions studied
Advanced Solid Tumor, Metastatic Solid Tumor, Prostate Cancer, Pancreas Cancer, Breast Cancer, Ovarian Cancer, Homologous Recombination Deficiency
About this study
This Phase 1, multi-center, open-label, dose escalation and dose optimization study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and preliminary clinical activity of MOMA-313 administered orally as a single agent or combination therapy in patients with homologous recombinant deficient solid tumors.
Interventions
- Drug: MOMA-313 — MOMA-313 administered orally
- Drug: Olaparib — Olaparib administered orally
Primary outcomes
- Number of participants with AEs, dose-limiting toxicities (DLTs), serious AEs (SAEs), and/or AEs leading to discontinuation (From screening until treatment discontinuation (up to 35 months))
Eligibility information
Key Inclusion Criteria:
1. Age ≥ 18 years
2. Have histologically confirmed disease for each treatment arm as follows:
1. Treatment Arm 1 (MOMA-313 Monotherapy)
\- Advanced (including locally), relapsed or metastatic solid tumors that are not eligible for curative therapy, with any HR-deficient alteration.
2. Treatment Arm 2 (MOMA-313 in Combination with Olaparib):
* Dose escalation: Advanced (including locally), relapsed or metastatic solid tumors that are not eligible for curative therapy, for which a PARP inhibitor is indicated, with select HR-deficient mutations. Patients may be PARP inhibitor naive or exposed.
* Dose optimization: Advanced (including locally), relapsed or metastatic CRPC or pancreatic ductal adenocarcinoma (PDAC) with select HR-deficient mutations. Patients must be PARP inhibitor naive.
3. Have at least 1 lesion at baseline (measurable or non-measurable) suitable for repeat imaging evaluation by RECIST and/or PCWG-3
4. ECOG PS ≤ 2
5. Fully recovered from clinically relevant effects of prior therapy, radiotherapy, and/or surgery \*\*hormonal therapy allowed. Palliative radiotherapy allowed.
6. Adequate organ function per local labs
7. Comply with contraception requirements
8. Written informed consent must be obtained according to local guidelines
Key Exclusion Criteria:
1. Active prior or concurrent malignancy (some exceptions allowed)
2. Clinically relevant cardiovascular disease
3. Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed)
4. Known active infection
5. Prior polymerase theta inhibitor exposure
6. Known allergy, hypersensitivity, and/or intolerance to MOMA-313
7. Olaparib exposed patients with known hypersensitivity to PARP inhibitors (for patients considered for olaparib only)
8. Impaired GI function that may impact absorption.
9. Patient is pregnant or breastfeeding.
10. Known to be HIV positive, unless all of the following criteria are met:
1. Undetectable viral load or CD4+ count ≥300 cells/μL
2. Receiving highly active antiretroviral therapy
3. No AIDS-related illness within the past 12 months
11. Active liver disease (some exceptions are allowed)
12. Prior or ongoing condition, therapy, or laboratory abnormality that, in the investigator's opinion, may affect safety of the patient, confound the results of the study, and/or interfere with the patients participation in the study
Study locations
- Investigative Site #108, Goodyear, Arizona 85338 United States
- Investigative Site #101, La Jolla, California 92093 United States
- Investigative Site #111, San Francisco, California 94143 United States
- Investigative Site #104, Lake Mary, Florida 32746 United States
- Investigative Site #110, St Louis, Missouri 63110 United States
- Investigative Site #103, New York, New York 10016 United States
- Investigative Site #106, New York, New York 10065 United States
- Investigative Site #109, Philadelphia, Pennsylvania 19104 United States
- Investigative Site #107, Myrtle Beach, South Carolina 29572 United States
- Investigative Site #102, Nashville, Tennessee 37203 United States
Showing 10 of 18 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.