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.
- Diseases
- Triple-negative breast cancer, Head and neck cancer, Endometrial cancer, Cervical cancer, Ovarian cancer
- 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
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Normunity Investigational Site Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Normunity Investigational Site Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Normunity Investigational Site Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Normunity Investigational Site Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| Normunity Investigational Site Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| Normunity Investigational Site Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| Normunity Investigational Site Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Normunity Investigational Site Coordinator of this site? Confirm its status | Maumee | United States | Recruiting |
| Normunity Investigational Site Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Normunity Investigational Site Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Normunity Investigational Site Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Normunity Investigational Site Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| Normunity Investigational Site Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Normunity Investigational Site Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Normunity Investigational Site Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Normunity Investigational Site Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.