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

NCT06270706 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2026-04-20

No results posted yet for this study

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

Conditions

  • Advanced or Metastatic Solid Tumor

Interventions

DRUG

PLN-101095

PLN-101095 250 mg BID

DRUG

PLN-101095

PLN-101095 500 mg BID

DRUG

PLN-101095

PLN-101095 1000 mg BID

DRUG

PLN-101095

PLN-101095 1000 mg TID

DRUG

PLN-101095

PLN-101095 2000 mg BID

DRUG

PLN-101095

PLN-101095

DRUG

Pembrolizumab

Pembrolizumab (KEYTRUDA) 200 mg IV Q3W

Sponsors & Collaborators

  • Pliant Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Pliant Therapeutics Medical Monitor · Pliant Therapeutics, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-30
Primary Completion
2030-06-30
Completion
2030-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06270706 on ClinicalTrials.gov