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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
155
Orally available degrader of SMARCA2
Research Site
Scottsdale, Arizona, United States
NOT_YET_RECRUITINGResearch Site
Duarte, California, United States
NOT_YET_RECRUITINGResearch Site
Orange, California, United States
NOT_YET_RECRUITINGResearch Site
Boston, Massachusetts, United States
NOT_YET_RECRUITINGResearch Site
St Louis, Missouri, United States
NOT_YET_RECRUITINGResearch Site
New York, New York, United States
NOT_YET_RECRUITINGResearch Site
Durham, North Carolina, United States
NOT_YET_RECRUITINGResearch Site
Cleveland, Ohio, United States
NOT_YET_RECRUITINGResearch Site
San Antonio, Texas, United States
RECRUITINGResearch Site
Fairfax, Virginia, United States
RECRUITINGTreatment Emergent Adverse Events
Time frame: From enrollment to 28 days after the last dose of PLX-61639
Dose-Limiting Toxicities
Time frame: From enrollment to 28 days after first dose of PLX-61639
Dose reductions due to Adverse Events
Time frame: From Day 1 to the end of PLX-61639 treatment, an average of 1 year
Study treatment discontinuations for reasons other than disease progression
Time frame: From Day 1 to the end of PLX-61639 treatment, an average of 1 year
Pharmacokinetics of PLX-61639: Cmax
Time frame: From Day 1 to Day 15 of Cycle 1 (Part 1 only) (each cycle is 28 days)
Pharmacokinetics of PLX-61639: Tmax
Time frame: From Day 1 to Day 15 of Cycle 1 (Part 1 only) (each cycle is 28 days)
Pharmacokinetics of PLX-61639: AUC0-last
Time frame: From Day 1 to Day 16 of Cycle 1 (Part 1 only) (each cycle is 28 days)
Radiographic response to PLX-61639
Time frame: From Day 1 to the end of PLX-61639 treatment, an average of 1 year
Time to response (TTR) to PLX-61639
Time frame: From Day 1 to achievement of partial or complete response, up to 24 weeks
Duration of response (DoR) to PLX-61639
Time frame: From first documented partial or complete response to disease progression or death, an average of 1 year
Progression Free Survival (PFS) of PLX-61639
Time frame: From Day 1 to disease progression or death, an average of 1 year
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