PLX-61639 for advanced SMARCA4-deficient solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, single-arm, first-in-human Phase 1 trial of PLX-61639 given orally once daily to participants with relapsed or refractory, SMARCA4-deficient locally advanced or metastatic solid tumors. The study has three parts: dose escalation to find a safe dose, dose optimization, and cohort expansion to study activity in selected groups. Each participant undergoes up to 28 days of screening, then consecutive 28-day treatment cycles and post-treatment follow-up until progression, intolerance, death, or withdrawal. Key objectives include characterizing safety, pharmacokinetics, and preliminary antitumor activity by RECIST 1.1.

Why it matters

Who can join: the full rules

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 1

Key Exclusion Criteria:

* Germline SMARCA4 mutations
* Known SMARCA2 mutation or loss of expression
* Symptomatic CNS disease
* Prior treatment with another SMARCA2-directed therapy
* History of other malignancies
* Clinically significant heart disease
* Uncontrolled hypertension
* Prolongation of QT interval

Where it's running

• Research Site
  Scottsdale, Arizona, United States Recruiting
• Research Site
  Duarte, California, United States Recruiting
• Research Site
  Orange, California, United States Recruiting
• Research Site
  Boston, Massachusetts, United States Recruiting
• Research Site
  St Louis, Missouri, United States Recruiting
• Research Site
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Clinical Operations
• Email: ClinicalTrials@Plexium.com
• Phone: 619-631-3091

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.