RecruitingPhase 1NCT07182149

A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors

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

Sponsor

Normunity AccelCo, Inc.

Enrollment

150 participants

Start Date

Oct 30, 2025

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Cervical Cancer Endometrial Cancer Esophageal Adenocarcinoma NSCLC HNSCC Gastric Adenocarcinoma ESCC GEJ Adenocarcinoma

Summary

This study is being done to find out of NRM-823 is safe and can treat participants with locally advanced or metastatic solid tumors.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria4

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.