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

Condition(s) studied

Investigational drug(s) / intervention(s)

PLX-61639: Orally available degrader of SMARCA2

Study summary

A multicenter, single-arm, first-in-human study to investigate the safety, pharmacokinetics, and preliminary antitumor activity of PLX-61639 in participants with locally advanced or metastatic, relapsed/refractory, SMARCA4-deficient solid tumors who are intolerant of or have failed available, approved therapies.

The study will be conducted in 3 parts: dose escalation (Part 1), dose optimization (Part 2), and cohort expansion (Part 3). Each part of the study will consist of a Screening Phase lasting up to 28 days during which participants will be assessed for eligibility, a Treatment Phase beginning on Cycle 1 Day 1 and consisting of consecutive 28-day cycles, an End of Treatment Visit, and a Post-Treatment Follow-Up Phase.

Participants will receive their assigned dose of PLX-61639 administered orally, once daily until progression/relapse, intolerance, death, or withdrawal from study treatment by the Investigator or participant.

Eligibility

Primary outcome measure(s)

• Treatment Emergent Adverse Events — From enrollment to 28 days after the last dose of PLX-61639
• Dose-Limiting Toxicities — From enrollment to 28 days after first dose of PLX-61639

Trial sites (10)

Other trials for the same condition