RecruitingPhase 1NCT06270706

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

A Phase 1a/1b Multicenter, Open-label Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of PLN-101095 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Advanced or Metastatic Solid Tumors Who Have Disease Progression While on an Immune Checkpoint Inhibitor (FORTIFY)


Sponsor

Pliant Therapeutics, Inc.

Enrollment

124 participants

Start Date

Aug 30, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called PLN-101095, a drug called PLN-101095, and others for people with advanced or metastatic solid tumor. The study is currently recruiting participants at 6 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPLN-101095

PLN-101095 250 mg BID

DRUGPLN-101095

PLN-101095 500 mg BID

DRUGPLN-101095

PLN-101095 1000 mg BID

DRUGPLN-101095

PLN-101095 1000 mg TID

DRUGPLN-101095

PLN-101095 2000 mg BID

DRUGPLN-101095

PLN-101095

DRUGPembrolizumab

Pembrolizumab (KEYTRUDA) 200 mg IV Q3W


Locations(6)

Yale University

New Haven, Connecticut, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

South Texas Accelerated Research Therapeutics (START)

Grand Rapids, Michigan, United States

NEXT Austin

Austin, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

NEXT Virginia

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06270706


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