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 beg

Trial Details

NCT ID
NCT07284186
Phase
PHASE1
Sponsor
Plexium, Inc.
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • PLX-61639
Locations (sample)
  • Scottsdale, Arizona, United States|33.50921,-111.89903
  • Duarte, California, United States|34.13945,-117.97729
  • Orange, California, United States|33.78779,-117.85311
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • St Louis, Missouri, United States|38.62727,-90.19789

Key Eligibility Criteria

  • Participants with locally advanced or metastatic, relapsed/refractory, solid tumors harboring a SMARCA4 loss-of-function mutation that have progres…
  • Adequate liver bone marrow, coagulation, renal, and cardiopulmonary function
  • Measurable disease per RECIST 1.1
  • ECOG PS of 0 or 1

For full eligibility, visit ClinicalTrials.gov.

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