Actively Recruiting
A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
Led by Pliant Therapeutics, Inc. · Updated on 2026-04-20
124
Participants Needed
6
Research Sites
352 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced or metastatic solid tumor
- Received at least 12 weeks of continuous anti-PD-1 or anti-PD-L1 treatment alone or with other therapies
- Documented prior clinical benefit (complete or partial response, or stable disease for 6 months) for Part 2
- Developed radiographic disease progression during or within 12 weeks after anti-PD-1 or anti-PD-L1 treatment
- At least one measurable lesion by RECIST v1.1 criteria
- Estimated survival of at least 3 months
- Adequate bone marrow and organ function
- Female participants must not be pregnant or breastfeeding
You will not qualify if you...
- Immune-related medical conditions increasing risk with pembrolizumab
- Additional progressing malignancy requiring active treatment in past 2 years
- Prior radiotherapy within 2 weeks for bone therapy or 4 weeks for other radiotherapy
- Major surgery within 4 weeks before first dose or not recovered from surgery
- Immunodeficiency diagnosis or systemic steroids use over 10 mg/day
- Active autoimmune disease needing systemic treatment in past 2 years
- Known active central nervous system metastases
- Significant heart disease
- Active infection needing systemic therapy, including uncontrolled HIV, Hepatitis B or C
- Received live vaccine within 30 days or non-live vaccine within 7 days before first PLN-101095 dose
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Yale University
New Haven, Connecticut, United States, 06511
Active, Not Recruiting
2
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
South Texas Accelerated Research Therapeutics (START)
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
4
NEXT Austin
Austin, Texas, United States, 78758
Actively Recruiting
5
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
6
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
P
Pliant Therapeutics Medical Monitor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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