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Recruiting
NCT07182149
A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors
Conditions: HNSCC, ESCC, Esophageal Adenocarcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma, Ovarian Cancer, NSCLC, Cervical Cancer, Endometrial Cancer, Triple Negative Breast Cancer (TNBC)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 150
Sponsor: Normunity AccelCo, Inc.
Location: Normunity Investigational Site Denver Colorado
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.
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 \
Source: ClinicalTrials.gov (NCT07182149). StuddyBuddy aggregates publicly available trial information.