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NCT07182149PHASE1Recruiting

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

Normunity AccelCo, Inc.

Start Date

10/30/2025

Completion Date

10/31/2028

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.

Detailed Description

Part A of the study will evaluate the safety and tolerability of NRM-823. Part B of the study will further evaluate the safety and tolerability of NRM-823 of the recommended dose identified in PART A in an expansion cohort. Part C will evaluate the addition of a checkpoint inhibitor to NRM-823.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

NRM-823

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Conditions

HNSCCESCCEsophageal AdenocarcinomaGastric AdenocarcinomaGEJ AdenocarcinomaOvarian CancerNSCLCCervical CancerEndometrial CancerTriple Negative Breast Cancer (TNBC)

Locations

Normunity Investigational Site

Denver, Colorado 80220

United States

Normunity Investigational Site

New Haven, Connecticut 06519

United States

Normunity Investigational Site

Minneapolis, Minnesota 55425

United States

Normunity Investigational Site

Maumee, Ohio 43537

United States

Normunity Investigational Site

Philadelphia, Pennsylvania 19107

United States

Normunity Investigational Site

Nashville, Tennessee 37203

United States

Normunity Investigational Site

Dallas, Texas 75230

United States

Normunity Investigational Site

San Antonio, Texas 78229

United States

Normunity Investigational Site

Fairfax, Virginia 22031

United States