First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors
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.
Checked against the public recordLast updated Jun 12, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Plexium, Inc.
- Interventions being studied
- Drug: PLX-61639
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Research SiteScottsdale, Arizona
- Research SiteDuarte, California
- Research SiteOrange, California
- Research SiteBoston, Massachusetts
- Research SiteSt Louis, Missouri
- Research SiteNew York, New York
- Research SiteDurham, North Carolina
- Research SiteCleveland, Ohio
- Research SiteSan Antonio, Texas
- Research SiteFairfax, Virginia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 12, 2026. Always confirm current availability with the study team.