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RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 28 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests PLX-61639 in people for the first time to learn about its safety, how the body handles it, and whether it fights cancer. It is for people with solid tumors that have a SMARCA4 gene change, have grown nearby or spread, and have come back or resisted treatment. Participants take the drug by mouth once a day.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a solid tumor that has grown nearby or spread and has come back or resisted treatment.
  • The tumor has a SMARCA4 gene change that stops the gene from working.
  • Approved treatments have not worked, cannot be tolerated, or are not suitable.
  • Have good enough liver, kidney, heart, and lung function, blood cell production, and blood clotting.
  • Have cancer that can be measured using the study’s rules.
  • Are fully active or can do light work but not heavy physical activity.

Who can't join

  • Have an inherited SMARCA4 gene change.
  • Have a known SMARCA2 gene change or lack of SMARCA2 activity.
  • Have disease in the brain or spinal cord that causes symptoms.
  • Have already received treatment aimed at SMARCA2.
  • Have a history of other cancers.
  • Have significant heart disease.
  • Have high blood pressure that is not controlled.
  • Have a long QT interval, meaning the heart takes longer than normal to reset between beats.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (10)

AZ

CA

MA

MO

NC

NY

OH

TX

VA