Status:
RECRUITING
A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors
Lead Sponsor:
Normunity AccelCo, Inc.
Conditions:
HNSCC
ESCC
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is being done to find out of NRM-823 is safe and can treat participants with locally advanced or metastatic solid tumors.
Detailed Description
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 ...
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.
Key Trial Info
Start Date :
October 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07182149
Start Date
October 30 2025
End Date
October 31 2028
Last Update
November 6 2025
Active Locations (3)
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1
Normunity Investigational Site
Nashville, Tennessee, United States, 37203
2
Normunity Investigational Site
San Antonio, Texas, United States, 78229
3
Normunity Investigational Site
Fairfax, Virginia, United States, 22031