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

Description

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

Conditions

Metastatic Solid Tumor

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Study Overview

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Study Details

Study overview

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

A Phase 1a/1b Multicenter, Open-label Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of PLN-101095 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Advanced or Metastatic Solid Tumors Who Have Disease Progression While on Pembrolizumab

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

Condition
Metastatic Solid Tumor
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale University, New Haven, Connecticut, United States, 06511

Grand Rapids

South Texas Accelerated Research Therapeutics (START), Grand Rapids, Michigan, United States, 49546

Austin

NEXT Austin, Austin, Texas, United States, 78758

Houston

University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

Fairfax

NEXT Virginia, Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Has histologically or cytologically confirmed advanced solid tumor
  • 2. Has an advanced or metastatic solid tumor (for which pembrolizumab is indicated) and have evidence of disease progression after treatment with pembrolizumab.
  • 3. At least 1 measurable lesion, as defined by RECIST v1.1
  • 4. Estimated survival of ≥3 months
  • 5. No effective therapeutic options available (eg, has received standard of care or is intolerant of, refuses, or is not eligible for standard of care antineoplastic therapy)
  • 1. Any immune-related medical conditions that would put participants at greater risk when receiving pembrolizumab
  • 2. Previous treatment with pembrolizumab \<21 days prior to the first dose of combination therapy of pembrolizumab and PLN-101095
  • 3. Received an immunotherapy other than pembrolizumab in the last 4 weeks prior to the first dose of PLN-101095
  • 4. Received radiotherapy (RT) within 1 week for palliative bone-directed therapy and 4 weeks for all other types, prior to the first dose of PLN-101095
  • 5. Received chemotherapy or other targeted therapies within 2 weeks prior to the first dose of PLN-101095
  • 6. Received a cell therapy within the last 12 months prior to the first dose of PLN-101095
  • 7. Known active central nervous system (CNS) metastases (brain and/or leptomeningeal metastases)
  • 8. Pregnant or lactating female participant

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pliant Therapeutics, Inc.,

Pliant Therapeutics Medical Monitor, STUDY_DIRECTOR, Pliant Therapeutics, Inc.

Study Record Dates

2025-12