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

Recruiting now · Phase 1

Conditions studied: HNSCC, ESCC, Esophageal Adenocarcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma, Ovarian Cancer, NSCLC, Cervical Cancer, Endometrial Cancer, Triple Negative Breast Cancer (TNBC)

In brief

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

Key facts

Study ID

NCT07182149

Run by

Normunity AccelCo, Inc.

People needed

150

Starts

2025-10-30

Expected to finish

2028-10-31

Last updated by the study team

2026-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Normunity Investigational Site — Denver, Colorado, United States (enrolling)
• Normunity Investigational Site — New Haven, Connecticut, United States (enrolling)
• Normunity Investigational Site — Minneapolis, Minnesota, United States (enrolling)
• Normunity Investigational Site — Maumee, Ohio, United States (enrolling)
• Normunity Investigational Site — Philadelphia, Pennsylvania, United States (enrolling)
• Normunity Investigational Site — Nashville, Tennessee, United States (enrolling)
• Normunity Investigational Site — Dallas, Texas, United States (enrolling)
• Normunity Investigational Site — San Antonio, Texas, United States (enrolling)
• Normunity Investigational Site — Fairfax, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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