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NCT07182149RecruitingPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 18 Aug 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
150 (estimated)
First submitted
11 Sept 2025
Start date
30 Oct 2025
Primary completion date
30 May 2027
Lead sponsor
Normunity AccelCo, Inc.
NCT number
NCT07182149

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 150
  • From 30 Oct 2025 to the primary completion date, 30 May 2027
  • 16 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (16)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Normunity Investigational Site
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Normunity Investigational Site
Coordinator of this site? Confirm its status
CharlestonUnited StatesRecruiting
Normunity Investigational Site
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
Normunity Investigational Site
Coordinator of this site? Confirm its status
DenverUnited StatesRecruiting
Normunity Investigational Site
Coordinator of this site? Confirm its status
FairfaxUnited StatesRecruiting
Normunity Investigational Site
Coordinator of this site? Confirm its status
HackensackUnited StatesRecruiting
Normunity Investigational Site
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Normunity Investigational Site
Coordinator of this site? Confirm its status
MaumeeUnited StatesRecruiting
Normunity Investigational Site
Coordinator of this site? Confirm its status
MinneapolisUnited StatesRecruiting
Normunity Investigational Site
Coordinator of this site? Confirm its status
NashvilleUnited StatesRecruiting
Normunity Investigational Site
Coordinator of this site? Confirm its status
New HavenUnited StatesRecruiting
Normunity Investigational Site
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesRecruiting
Normunity Investigational Site
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
Normunity Investigational Site
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
Normunity Investigational Site
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
Normunity Investigational Site
Coordinator of this site? Confirm its status
Washington D.C.United StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.