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Phase 1 Study of NRM-823 for Advanced Solid Tumors

This study is testing a drug called NRM-823 to see if it's safe and effective for people with locally advanced or metastatic (spread to other parts of the body) solid tumors, including certain types of head and neck, esophageal, stomach, and GEJ (where the esophagus meets the stomach) cancers. NRM-823 is a bispecific T-Cell Engager, which means it helps your immune system fight cancer. The study will first look at the safety and side effects of NRM-823 alone, and then explore adding a checkpoint inhibitor (another type of immunotherapy) to NRM-823. The main goals are to track any side effects and see how well participants tolerate the treatment. We don't have information on the current recruitment status.

Study design
This is a Phase 1 interventional study planning to enroll 150 participants. It will evaluate NRM-823 in different parts, including an expansion cohort and with a checkpoint inhibitor.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for treatment-emergent adverse events and dose-limiting toxicities from enrollment until 30 days after their last dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07182149

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Normunity AccelCo, Inc.
~150 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:NRM-823

At a glance

Recruiting sites
18 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment-emergent adverse events (TEAE)
Measured over From enrollment until 30 days post the last dose received by a participant
+1 more outcome measured

Conditions

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

Explore related trials

Cervical CarcinomaEndometrial CarcinomaEsophageal AdenocarcinomaEsophageal Squamous Cell CarcinomaGastric AdenocarcinomaGastroesophageal Junction AdenocarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaMalignant Ovarian NeoplasmSolid NeoplasmTriple-negative breast cancer

Where it's being run

18 sites across 14 states
Texas3
Massachusetts2
Pennsylvania2
Colorado1
Connecticut1
District of Columbia1
Minnesota1
Missouri1

Study leadership

  • Viviana Bozon, MD · STUDY_DIRECTOR · Normunity AccelCo, Inc.

Who to contact

Judy Schnyder, MBA
[email protected]
215-593-7119
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Incidence of treatment-emergent adverse events (TEAE)From enrollment until 30 days post the last dose received by a participant

    Number of participants who experience treatment emergent AEs or SAEs

  • Incidence of dose-limiting toxicities (DLTs)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.