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

February 13, 2024 updated by: Pliant Therapeutics, Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

77

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • South Texas Accelerated Research Therapeutics (START)
    • Texas
      • Austin, Texas, United States, 78758
        • Recruiting
        • NEXT Austin
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Next Virginia

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion 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)

Exclusion Criteria:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1 Dose Escalation: PLN-101095 given as monotherapy and in combination with Pembrolizumab
Drug: Pembrolizumab
Pembrolizumab
Drug: PLN-101095
PLN-101095
Experimental: Part 2 Dose Expansion: PLN-101095 in combination with Pembrolizumab
Drug: Pembrolizumab
Pembrolizumab
Drug: PLN-101095
PLN-101095

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants with treatment-emergent adverse events and serious adverse events per CTCAE Version 5.0.
Time Frame: Signing ICF until 16 weeks after end of study treatment regimen
Signing ICF until 16 weeks after end of study treatment regimen
Number of participants with a Dose Limiting Toxicity (DLT) defined as toxicities that meet predefined severity criteria, assess as having a suspected relationship to study drug, unrelated to disease, inter-current illness, or concomitant medications.
Time Frame: First dose to 35 days
First dose to 35 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum observed plasma concentration (Cmax) to characterize the plasma pharmacokinetics (PK).
Time Frame: First dose until 10 weeks
First dose until 10 weeks
Time to maximum observed concentration (Tmax) to characterize the plasma pharmacokinetics (PK).
Time Frame: First dose until 10 weeks
First dose until 10 weeks
Area under the concentration-time curve over a dosing interval (AUC0-τ) to characterize the plasma pharmacokinetics (PK).
Time Frame: First dose until 10 weeks
First dose until 10 weeks
Disease control rate (DCR) is defined by the proportion of participants who maintain disease control (iCR, iPR or iSD) per iRECIST Version 1.1.
Time Frame: Day 1 until end of study treatment regimen
Day 1 until end of study treatment regimen
Objective response rate (ORR) is defined by the proportion of participants with an iCR or iPR per iRECIST Version 1.1.
Time Frame: Day 1 until end of study treatment regimen
Day 1 until end of study treatment regimen

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pliant Therapeutics, Inc.

Investigators

  • Study Director: Pliant Therapeutics Medical Monitor, Pliant Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 26, 2024

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Estimated)

February 21, 2024

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLN-101095-ONC-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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