Home › Head and Neck Squamous Cell Carcinoma › NCT07182149
A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors
RecruitingPhase 1
A Phase 1a/1b Study of NRM-823 as Monotherapy and in Combination With Immune Checkpoint Inhibition in Participants With Locally Advanced or Metastatic Refractory Solid Tumors
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the 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.
What is being tested
- NRM-823 (drug)
Sponsor: Normunity AccelCo, Inc. · Participants: 150 · Started: Oct 30, 2025
Contact the study team
- Judy Schnyder, MBA · Phone: 215-593-7119
Official record on ClinicalTrials.gov — NCT07182149
Locations in the U.S.
Conditions
- Head and Neck Squamous Cell Carcinoma
- Esophageal Adenocarcinoma
- Ovarian Cancer
- Cervical Cancer
- Endometrial Cancer
- Triple-Negative Breast Cancer
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.