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Trial NCT07182149

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

Phase
Phase 1
Sponsor
Normunity AccelCo, Inc.
Conditions
HNSCC; ESCC; Esophageal Adenocarcinoma; Gastric Adenocarcinoma; GEJ Adenocarcinoma; Ovarian Cancer; NSCLC; Cervical Cancer; Endometrial Cancer; Triple Negative Breast Cancer (TNBC)
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

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.Performance status * 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.

Restrictions found (1)

Recruiting in Massachusetts

  • Normunity Investigational Site · Boston, Suffolk County
  • Normunity Investigational Site · Boston, Suffolk County