RecruitingPhase 1NCT07284186

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


Sponsor

Plexium, Inc.

Enrollment

155 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This first-in-human study is testing a new drug called PLX-61639 in patients with advanced solid tumors that have a specific genetic change called a SMARCA4 loss-of-function mutation — a change that makes cancer cells rely on a related protein called SMARCA2 to survive. **You may be eligible if...** - You have a locally advanced or metastatic solid tumor with a confirmed SMARCA4 loss-of-function mutation - Your cancer has progressed on or you could not tolerate all available approved treatments - You have measurable disease on imaging scans - Your general health score (ECOG) is 0 or 1 (fully active or restricted in strenuous activity only) - Your liver, kidneys, bone marrow, and heart function are adequate **You may NOT be eligible if...** - You have a germline (inherited) SMARCA4 mutation or a known SMARCA2 mutation - Your cancer has spread to the brain and is causing symptoms - You have received prior SMARCA2-directed therapy - You have a history of other cancers, significant heart disease, uncontrolled high blood pressure, or a prolonged QT interval on ECG Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPLX-61639

Orally available degrader of SMARCA2


Locations(10)

Research Site

Scottsdale, Arizona, United States

Research Site

Duarte, California, United States

Research Site

Orange, California, United States

Research Site

Boston, Massachusetts, United States

Research Site

St Louis, Missouri, United States

Research Site

New York, New York, United States

Research Site

Durham, North Carolina, United States

Research Site

Cleveland, Ohio, United States

Research Site

San Antonio, Texas, United States

Research Site

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT07284186


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