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

StatusRecruiting
PhasePhase 1
Started

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Record History

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  1. Trial sites expanded: 12 → 22 locations
    • Eligibility criteria expanded, about 18 words
  2. Trial sites expanded: 6 → 12 locationsv4
  3. Enrollment target: 77 to 124v3 Show 8 more changesShow less
    • Primary completion date: Jun 2025 to Jun 2030
    • Primary endpoints: 2 to 4
    • Study sites: 5 to 6
    • Study completion date: Dec 2025 to Jun 2030
    • Interventions: PLN-101095 (Drug), Pembrolizumab (Drug) to PLN-101095 (Drug), PLN-101095 (Drug), PLN-101095 (Drug), PLN-101095 (Drug), PLN-101095 (Drug), PLN-101095 (Drug), Pembrolizumab (Drug)
    • Eligibility criteria expanded, about 74 words
    • Secondary endpoints revised (5)
    • Study arms: 2 to 8
  4. Study sites: 4 to 5v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pliant Therapeutics, Inc.
3 trials monitored
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Breast Cancer
5,455 trials monitored
See 306 trials at risk
Lung Cancer
4,798 trials monitored
See 270 trials at risk
Colorectal Cancer
3,405 trials monitored
See 162 trials at risk
and 7 more diseases
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
Trial Details
NCT Number NCT06270706
Lead Sponsor Pliant Therapeutics, Inc.
Conditions
(from sponsor)		 Advanced or Metastatic Solid Tumor
Related terms Anus Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Cholangiocarcinoma, Colorectal Neoplasms, Endometrial Neoplasms, Melanoma, Neoplasm Metastasis, Ovarian Neoplasms, Triple Negative Breast Neoplasms
Enrollment 124 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov