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Trial NCT07284186

First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors

Phase
Phase 1
Sponsor
Plexium, Inc.
Conditions
Esophageal Squamous Cell Carcinoma; Gastric Adenocarcinoma; Gastric Squamous Cell Carcinoma; Gastroesophageal Junction (GEJ) Adenocarcinoma; Metastatic Solid Tumor; Non-Small Cell Lung Carcinoma; Esophageal Adenocarcinoma; SMARCA4 Mutation; Gastroesophageal Junction Squamous Cell Carcinoma; Advanced Solid Tumor
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).

Key Inclusion Criteria: * Participants with locally advanced or metastatic, relapsed/refractory, solid tumors harboring a SMARCA4 loss-of-function mutation that have progressed on, are intolerant of, or not otherwise candidates for available approved therapies * Adequate liver bone marrow, coagulation, renal, and cardiopulmonary function * Measurable disease per RECIST 1.1 * ECOG PS of 0 or 1Performance status Key Exclusion Criteria: * Germline SMARCA4 mutations * Known SMARCA2 mutation or loss of expression * Symptomatic CNS diseaseBrain metastases * Prior treatment with another SMARCA2-directed therapy * History of other malignanciesPrior malignancy * Clinically significant heart disease * Uncontrolled hypertension * Prolongation of QT intervalCardiac

Restrictions found (4)

Recruiting in Massachusetts

  • Research Site · Boston, Suffolk County