Condition: Advanced or Metastatic Solid Tumor · Sponsor: Pliant Therapeutics, Inc.
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: Consecutive dose-escalation cohorts using a Bayesian optimal interval (BOIN) dose escalation design with accelerated titration * Part 2: Dose-expansion cohorts using Simon's 2-stage design
This description comes directly from the study's public registry record.
Pliant Therapeutics Medical Monitor · clintrials@pliantrx.com · clintrials@pliantrx.com
Always discuss trial participation with your own doctor first.
| Yale University | New Haven, Connecticut, United States | Active Not Recruiting |
| Winship Cancer Institute of Emory University | Atlanta, Georgia, United States | Recruiting |
| South Texas Accelerated Research Therapeutics (START) | Grand Rapids, Michigan, United States | Recruiting |
| NEXT Austin | Austin, Texas, United States | Recruiting |
| University of Texas MD Anderson Cancer Center | Houston, Texas, United States | Recruiting |
| NEXT Virginia | Fairfax, Virginia, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06270706