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
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)
- Brain metastasesConditionalexclusionShow in the text
- CardiacOutrightexclusionShow in the text
- Performance statusOutrightinclusion
ECOG PS 0 or 1
Show in the text - Prior malignancyOutrightexclusionShow in the text
Recruiting in Massachusetts
- Research Site · Boston, Suffolk County