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
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)
- Performance statusOutrightinclusion
ECOG 0 or 1
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Recruiting in Massachusetts
- Normunity Investigational Site · Boston, Suffolk County
- Normunity Investigational Site · Boston, Suffolk County