Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07284186

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

A Phase 1, First-in-Human Study of the SMARCA2 Degrader, PLX-61639, in Patients With SMARCA4-Mutated Locally Advanced or Metastatic Solid Tumors

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
155 (estimated)
Sponsor
Plexium, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGPLX-61639Orally available degrader of SMARCA2

Timeline

Start date
2025-12-01
Primary completion
2029-12-01
Completion
2030-09-01
First posted
2025-12-16
Last updated
2026-04-13

Locations

10 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07284186. Inclusion in this directory is not an endorsement.