Recruiting

NRM-823 for Advanced or Metastatic Refractory Solid Tumors

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What is being tested

NRM-823

Drug
Who is being recruted

Squamous Cell Carcinoma of Head and Neck+28

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorNormunity AccelCo, Inc.
Study ContactJudy Schnyder, MBA
Last updated: February 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 30, 2025

Actual date on which the first participant was enrolled.

This clinical trial focuses on testing a new drug called NRM-823, designed for people with advanced or hard-to-treat solid tumors. The trial aims to determine how safe this drug is when used alone and in combination with another type of cancer treatment known as immune checkpoint inhibitors. These inhibitors help the immune system recognize and attack cancer cells more effectively. This study is important because it explores new treatment options for patients whose tumors have not responded well to existing therapies, potentially offering new hope for managing their condition. Participants in this study will receive NRM-823 either by itself or alongside an immune checkpoint inhibitor. The study is divided into three parts. Initially, the research focuses on finding the safest dose of NRM-823 alone. After identifying this dose, the research will test its effects further in a larger group. In the final part, the study will examine how well the drug works when combined with the checkpoint inhibitor. The main focus is to observe any side effects participants might experience and to evaluate how the combination impacts the tumors. The results will help determine the best way to use these treatments together in the future.

Official TitleA 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
NCT07182149
Principal SponsorNormunity AccelCo, Inc.
Study ContactJudy Schnyder, MBA
Last updated: February 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Squamous Cell Carcinoma of Head and NeckUrogenital DiseasesGenital DiseasesAdnexal DiseasesBreast DiseasesBreast NeoplasmsCarcinomaCarcinoma, Squamous CellUterine Cervical DiseasesUterine Cervical NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersHead and Neck NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialOvarian DiseasesOvarian NeoplasmsSkin DiseasesUrogenital NeoplasmsUterine DiseasesUterine NeoplasmsEndometrial NeoplasmsSkin and Connective Tissue DiseasesFemale Urogenital DiseasesTriple Negative Breast Neoplasms

Criteria

4 inclusion criteria required to participate
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.

4 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Administered per protocol requirements

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

Recruiting

Normunity Investigational Site

Denver, United StatesOpen Normunity Investigational Site in Google Maps
Recruiting

Normunity Investigational Site

New Haven, United States
Recruiting

Normunity Investigational Site

Minneapolis, United States
Recruiting

Normunity Investigational Site

Maumee, United States
Recruiting
9 Study Centers