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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06270706
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Pliant Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Pliant Therapeutics Medical Monitor
Principal Investigator Affiliation Pliant Therapeutics, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Metastatic Solid Tumor
Arms & Interventions

Arms

Experimental: Part 1 Dose Escalation: PLN-101095 given as monotherapy and in combination with Pembrolizumab

Experimental: Part 2 Dose Expansion: PLN-101095 in combination with Pembrolizumab

Interventions

Drug: - PLN-101095

PLN-101095

Drug: - Pembrolizumab

Pembrolizumab

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Yale University, New Haven 4839366, Connecticut 4831725

Status

Recruiting

Address

Yale University

New Haven 4839366, Connecticut 4831725, 06511

Grand Rapids 4994358, Michigan 5001836

Status

Recruiting

Address

South Texas Accelerated Research Therapeutics (START)

Grand Rapids 4994358, Michigan 5001836, 49546

NEXT Austin, Austin 4671654, Texas 4736286

Status

Recruiting

Address

NEXT Austin

Austin 4671654, Texas 4736286, 78758

Houston 4699066, Texas 4736286

Status

Recruiting

Address

University of Texas MD Anderson Cancer Center

Houston 4699066, Texas 4736286, 77030

NEXT Virginia, Fairfax 4758023, Virginia 6254928

Status

Recruiting

Address

NEXT Virginia

Fairfax 4758023, Virginia 6254928, 22031

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