What is NRM-823 studying for refractory solid tumors?

NRM-823 is being studied to evaluate its safety and tolerability in adults with locally advanced or metastatic solid tumors that have not responded to prior treatments. The trial also looks at combining NRM-823 with an immune checkpoint inhibitor to see if this combination is safe. This research is sponsored by Normunity AccelCo, Inc.

Who may be eligible for this refractory solid tumors clinical trial?

Adults aged 18 years or older with certain advanced or metastatic solid tumors such as lung, breast, head and neck, esophageal, gastric, cervical, endometrial, or ovarian cancers may be eligible. Participants must have a good performance status and adequate organ function. They should not have recent cancer treatments or unresolved severe side effects. Please review eligibility criteria for more details.

Is there any cost to participate in this refractory solid tumors clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs related to travel or lodging.

Actively Recruiting

Phase 1

Age: 18Years +

All Genders

ID07182149

Phase 1 Study of NRM-823 Alone and Combined With Checkpoint Inhibitors for Advanced or Metastatic Refractory Solid Tumors

Led by Normunity AccelCo, Inc. · Updated on 2026-02-12

150

Participants Needed

Research Sites

74 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating NRM-823, a bispecific T-Cell Engager drug, in adults with locally advanced or metastatic solid tumors that are refractory to treatment. The study focuses on cancers including non-small cell lung cancer, triple negative breast cancer, head and neck squamous cell carcinoma, esophageal and gastric adenocarcinomas, cervical, endometrial, and ovarian cancers. The trial aims to assess the safety and tolerability of NRM-823 alone and in combination with an immune checkpoint inhibitor. The study is divided into three parts. Part A evaluates the safety and tolerability of NRM-823 alone to identify a recommended dose. Part B further assesses safety and tolerability of that dose in a larger group of participants. Part C investigates the safety and tolerability of NRM-823 combined with a checkpoint inhibitor. Treatments are administered according to protocol requirements throughout these phases. Participants will be monitored from enrollment until 30 days after their last dose for treatment-emergent adverse events and dose-limiting toxicities. The study includes assessments of liver, kidney, lung, heart, and blood function to ensure safety. Participants will be followed closely to evaluate how their bodies tolerate the treatment and to gather information on side effects during and after the treatment period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Have histologically- or cytologically-diagnosed advanced or metastatic NSCLC (squamous or adenocarcinoma), TNBC, HNSCC, ESCC, esophageal adenocarcinoma, gastric/GEJ adenocarcinoma, cervical, endometrial, or ovarian cancer
Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Adequate liver, renal, pulmonary, and cardiac function
Adequate hematologic function

You will not qualify if you...

Received cytotoxic chemotherapy, biologic anticancer agents, checkpoint inhibitors, or radiation therapy (excluding bone-only radiation) within 3 weeks or 5 half-lives prior to first dose
History of Grade 2 pneumonitis requiring steroids or any Grade 3 or 4 pneumonitis from prior therapy
Received investigational therapy within 4 weeks or 5 half-lives prior to first dose
Any unresolved toxicities from prior therapy greater than Grade 1 (except alopecia and Grade 2 or less neuropathy) at study start

Research Team

Judy Schnyder, MBA

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