Recruiting

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

ClinicalTrials.gov IDNCT06270706

PhasePHASE1

Enrollment124

SponsorPliant Therapeutics, Inc.

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Advanced or Metastatic Solid Tumor

About this study

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

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

Primary outcomes

Safety and tolerability of PLN-101095 in combination with pembrolizumab in Parts 1 and 2 (First dose to 35 days)
Safety and tolerability of PLN-101095 in combination with pembrolizumab in Parts 1 and 2 (Day 1 until 16 weeks after end of study treatment regimen)
Anti-tumor activity of PLN-101095 in combination with pembrolizumab in Part 2 (First dose to disease progression or death from any cause, whichever occurs first.)
Anti-tumor activity of PLN-101095 in combination with pembrolizumab in Part 2 (First dose to disease progression or death from any cause, whichever occurs first.)

Eligibility information

Inclusion Criteria: 1. Has histologically or cytologically confirmed advanced or metastatic solid tumor 2. Have received ≥12 weeks of continuous anti-PD-1 or anti-PD-L1 treatment administered as monotherapy or in combination with other anticancer therapies 3. Have demonstrated documented prior clinical benefit, defined as CR or PR at any time during treatment, or SD lasting ≥6 months (Part 2 only) 4. Must have subsequently developed radiographic disease progression while receiving anti-PD-1 or anti-PD-L1 treatment or within ≤12 weeks after the last dose of such treatment 5. At least 1 measurable lesion, as defined by RECIST v1.1 6. Estimated survival of ≥3 months 7. Have adequate bone marrow and organ function. 8. A female participant is eligible to participate if she is not pregnant, not breastfeeding Exclusion Criteria: 1. Any immune-related medical conditions that would put participants at greater risk when receiving pembrolizumab 2. Has a known additional malignancy that is progressing or has required active treatment within the past 2 years 3. Has received prior radiotherapy within 2 weeks for palliative bone-directed therapy and 4 weeks for all other radiotherapy 4. Has undergone major surgery within 4 weeks prior to the first dose of study treatment or has not adequately recovered from surgery or related complications 5. Has a diagnosis of immunodeficiency or use of systemic steroids \>10 mg/day 6. Has an active autoimmune disease that has required systemic treatment in the past 2 years 7. Has known active CNS metastases (brain and/or leptomeningeal metastases) 8. Has significant cardiac disease 9. Has an active infection requiring systemic therapy (including uncontrolled HIV, Hepatitis B and C) 10. Has received a live or live-attenuated vaccine within 30 days or a non-live vaccine within 7 days prior to the first dose of PLN-101095

Study locations

Yale University, New Haven, Connecticut 06511 United States
Winship Cancer Institute of Emory University, Atlanta, Georgia 30322 United States
South Texas Accelerated Research Therapeutics (START), Grand Rapids, Michigan 49546 United States
START New Jersey, East Brunswick, New Jersey 08816 United States
START New York Long Island LLC, Lake Success, New York 11042 United States
Carolina Cancer Research Center, Wilson, North Carolina 27893 United States
NEXT Austin, Austin, Texas 78758 United States
START Center for Clinical Research, Fort Worth, Texas 76104 United States
University of Texas MD Anderson Cancer Center, Houston, Texas 77030 United States
NEXT Houston, Houston, Texas 77054 United States

Showing 10 of 12 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.