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
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.