A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors

This is a Phase 1a/1b, dose-escalation/expansion, consecutive-cohort, open-label study to evaluate the safety, tolerability, PK, PD, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab (the study treatment regimen) in adult participants with advanced or metastatic solid tumors for which pembrolizumab is indicated but have documented disease progression (refractory \[primary resistance\]) or relapsed \[secondary resistance\]) after at least 3 months from the start of treatment with pembrolizumab. The study will consist of 2 main parts: * Part 1: Cons

Trial Details

NCT ID
NCT06270706
Phase
PHASE1
Sponsor
Pliant Therapeutics, Inc.
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • PLN-101095
  • Pembrolizumab
Locations (sample)
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Grand Rapids, Michigan, United States|42.96336,-85.66809
  • Austin, Texas, United States|30.26715,-97.74306
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Has histologically or cytologically confirmed advanced or metastatic solid tumor
  • Have received ≥12 weeks of continuous anti-PD-1 or anti-PD-L1 treatment administered as monotherapy or in combination with other anticancer therapies
  • Have demonstrated documented prior clinical benefit, defined as CR or PR at any time during treatment, or SD lasting ≥6 months (Part 2 only)
  • Must have subsequently developed radiographic disease progression while receiving anti-PD-1 or anti-PD-L1 treatment or within ≤12 weeks after the l…

For full eligibility, visit ClinicalTrials.gov.

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