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

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

Plain Language Summary

Simplified for easier understanding

This is an early-stage trial testing a new drug called NRM-823 in people with various advanced or metastatic cancers, including lung, breast, head and neck, esophageal, stomach, cervical, endometrial, and ovarian cancers. The goal is to find a safe dose and look for early signs of effectiveness. **You may be eligible if...** - You have been diagnosed with advanced or metastatic non-small cell lung cancer, triple-negative breast cancer, head and neck cancer, esophageal cancer, gastric cancer, or gynecologic cancers (cervical, endometrial, ovarian) - You are in good general health (ECOG 0-1) - Your liver, kidneys, heart, and blood counts are within acceptable limits **You may NOT be eligible if...** - You have received chemotherapy, biological therapy, immunotherapy, or radiation within 3 weeks before starting the study drug - You have had serious lung inflammation (pneumonitis) requiring steroids from prior treatments - You have had a prior stem cell or organ transplant - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNRM-823

NRM-823 is a bispecific T-Cell Engager


Locations(9)

Normunity Investigational Site

Denver, Colorado, United States

Normunity Investigational Site

New Haven, Connecticut, United States

Normunity Investigational Site

Minneapolis, Minnesota, United States

Normunity Investigational Site

Maumee, Ohio, United States

Normunity Investigational Site

Philadelphia, Pennsylvania, United States

Normunity Investigational Site

Nashville, Tennessee, United States

Normunity Investigational Site

Dallas, Texas, United States

Normunity Investigational Site

San Antonio, Texas, United States

Normunity Investigational Site

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT07182149


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