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

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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

What is being tested

Sponsor: Normunity AccelCo, Inc. · Participants: 150 · Started: Oct 30, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07182149

Locations in the U.S.

ColoradoNormunity Investigational Site, Denver
ConnecticutNormunity Investigational Site, New Haven
District of ColumbiaNormunity Investigational Site, Washington D.C.
MassachusettsNormunity Investigational Site, Boston
Normunity Investigational Site, Boston
MinnesotaNormunity Investigational Site, Minneapolis
MissouriNormunity Investigational Site, St Louis
New JerseyNormunity Investigational Site, Hackensack
OhioNormunity Investigational Site, Maumee
OklahomaNormunity Investigational Site, Oklahoma City
PennsylvaniaNormunity Investigational Site, Philadelphia
Normunity Investigational Site, Philadelphia
South CarolinaNormunity Investigational Site, Charleston
TennesseeNormunity Investigational Site, Nashville
TexasNormunity Investigational Site, Dallas
Normunity Investigational Site, Houston
Normunity Investigational Site, San Antonio
VirginiaNormunity Investigational Site, Fairfax

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.