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NCT Number: NCT07182149

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

This study is being done to find out of NRM-823 is safe and can treat participants with locally advanced or metastatic solid tumors.

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Key information

Conditions

HNSCC Adenocarcinoma Of Esophagus Adnexal Diseases Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Squamous Cell Cervical Cancer ESCC Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Esophageal Adenocarcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications GEJ Adenocarcinoma Gastric Adenocarcinoma Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Neoplasms NSCLC Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Skin Diseases Skin and Connective Tissue Diseases Squamous Cell Carcinoma of Head and Neck Triple Negative Breast Cancer (TNBC) Triple Negative Breast Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Normunity Investigational Site, Denver, Colorado, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NRM-823

Drug

NRM-823 is a bispecific T-Cell Engager

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAE)

    Time frame: From enrollment until 30 days post the last dose received by a participant

    Number of participants who experience treatment emergent AEs or SAEs

  2. Incidence of dose-limiting toxicities (DLTs)

    Time frame: From enrollment until 30 days post the last dose received by a participant

    Number of participants who experience a DLT. A DLTs include protocol defined adverse events.

Study contacts

Contact information is provided by the study sponsor or research team.

Judy Schnyder, MBA

CONTACT

[email protected]

215-593-7119

Sponsors and collaborators

Lead sponsor

Normunity AccelCo, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 19, 2025
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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