Recruiting
A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors
This study is being done to find out of NRM-823 is safe and can treat participants with locally advanced or metastatic solid tumors.
ClinicalTrials.gov IDNCT07182149
PhasePHASE1
Enrollment150
SponsorNormunity AccelCo, Inc.
Age18 Years
SexALL
Conditions studied
HNSCC, ESCC, Esophageal Adenocarcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma, Ovarian Cancer, NSCLC, Cervical Cancer, Endometrial Cancer, Triple Negative Breast Cancer (TNBC)
About this study
This study is being done to find out of NRM-823 is safe and can treat participants with locally advanced or metastatic solid tumors.
Interventions
- Drug: NRM-823 — NRM-823 is a bispecific T-Cell Engager
Primary outcomes
- Incidence of treatment-emergent adverse events (TEAE) (From enrollment until 30 days post the last dose received by a participant)
- Incidence of dose-limiting toxicities (DLTs) (From enrollment until 30 days post the last dose received by a participant)
Eligibility information
Inclusion Criteria:
* Have histologically- or cytologically-diagnosed NSCLC (squamous or adenocarcinoma), TNBC, HNSCC, ESCC, esophageal adenocarcinoma, gastric/GEJ adenocarcinoma, cervical, endometrial, or ovarian cancer which is advanced or metastatic.
* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Adequate liver, renal, pulmonary, and cardiac function.
* Adequate hematologic function.
Exclusion Criteria:
* Has received cytotoxic chemotherapy, biologic anticancer agents, checkpoint inhibitors, or radiation therapy (excluding bone-only radiation therapy) ≤3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of NRM-823
* History of Grade 2 pneumonitis requiring steroids or any Grade 3 or 4 pneumonitis from any prior therapy.
* Has received an investigational therapy \<4 weeks or 5 half-lives prior to the first dose of NRM823, whichever is shorter prior to the first dose of NRM-823.
* With the exception of alopecia and Grade ≤2 neuropathy, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study drug.
Study locations
- Normunity Investigational Site, Denver, Colorado 80220 United States
- Normunity Investigational Site, New Haven, Connecticut 06519 United States
- Normunity Investigational Site, Washington D.C., District of Columbia 20007 United States
- Normunity Investigational Site, Boston, Massachusetts 02114 United States
- Normunity Investigational Site, Boston, Massachusetts 02215 United States
- Normunity Investigational Site, Minneapolis, Minnesota 55425 United States
- Normunity Investigational Site, St Louis, Missouri 63108 United States
- Normunity Investigational Site, Hackensack, New Jersey 07601 United States
- Normunity Investigational Site, Maumee, Ohio 43537 United States
- Normunity Investigational Site, Oklahoma City, Oklahoma 73104 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: 2026-09-28.