First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors
Recruiting · NCT07284186 · Interventional (participants receive a specific treatment) · Lead sponsor: Plexium, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
10 locations listed across 9 US states.
- 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