NCT07182149

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Normunity AccelCo, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HNSCC
• ESCC
• Esophageal Adenocarcinoma
• Gastric Adenocarcinoma
• GEJ Adenocarcinoma
• Ovarian Cancer
• NSCLC
• Cervical Cancer
• Endometrial Cancer
• Triple Negative Breast Cancer (TNBC)

Interventions

Type	Name	Description
DRUG	NRM-823	NRM-823 is a bispecific T-Cell Engager

Timeline

• Start date: 2025-10-30
• Primary completion: 2027-05-30
• Completion: 2028-10-31
• First posted: 2025-09-19
• Last updated: 2026-02-12

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study