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Clinical Trial 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


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06270706
Study type Interventional
Source Pliant Therapeutics, Inc.
Contact Pliant Therapeutics Medical Monitor
Phone clintrials@pliantrx.com
Email clintrials@pliantrx.com
Status Recruiting
Phase Phase 1
Start date August 30, 2023
Completion date December 2025

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