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

Active:	Yes
Cancer Type:	Solid Tumor Unknown Primary	NCT ID:	NCT06270706
Trial Phases:	Phase I	Protocol IDs:	PLN-101095-ONC-101 (primary) NCI-2024-01965
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Pliant Therapeutics, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT06270706

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

- Part 2: Dose-expansion cohorts using Simon's 2-stage design

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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