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Monoclonal Antibodies

Part 2 Dose Expansion: PLN-101095 in combination with Pembrolizumab for Metastatic Tumor

Phase 1

Recruiting

Research Sponsored by Pliant Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has histologically or cytologically confirmed advanced solid tumor

No effective therapeutic options available (e.g., has received standard of care or is intolerant of, refuses, or is not eligible for standard of care antineoplastic therapy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first dose to 35 days

Awards & highlights

Study Summary

This trial is testing a new drug called PLN-101095 in combination with pembrolizumab for adults with advanced solid tumors. The study will look at the safety, effectiveness, and how

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors who have not responded to treatment with pembrolizumab after at least 3 months. Participants must have a type of tumor for which pembrolizumab is already indicated.Check my eligibility

What is being tested?

The study tests PLN-101095 in combination with pembrolizumab, assessing safety and how well it works against tumors. It has two parts: first, finding the right dose; second, expanding that dose to more people to see its effects.See study design

What are the potential side effects?

Possible side effects include those commonly associated with cancer treatments such as fatigue, nausea, skin reactions, immune-related issues like inflammation in organs due to an overactive immune response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is confirmed to be advanced through testing.

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I have no other effective treatment options for my cancer.

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My cancer has worsened after treatment with pembrolizumab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose to 35 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose to 35 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose to 35 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

Proportion of participants with treatment-emergent adverse events and serious adverse events per CTCAE Version 5.0.

Secondary outcome measures

Area under the concentration-time curve over a dosing interval (AUC0-τ) to characterize the plasma pharmacokinetics (PK).

Disease control rate (DCR) is defined by the proportion of participants who maintain disease control (iCR, iPR or iSD) per iRECIST Version 1.1.

Maximum observed plasma concentration (Cmax) to characterize the plasma pharmacokinetics (PK).

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2 Dose Expansion: PLN-101095 in combination with PembrolizumabExperimental Treatment2 Interventions

Group II: Part 1 Dose Escalation: PLN-101095 given as monotherapy and in combination with PembrolizumabExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pliant Therapeutics, Inc.Lead Sponsor

7 Previous Clinical Trials

656 Total Patients Enrolled

Pliant Therapeutics Medical MonitorStudy DirectorPliant Therapeutics, Inc.

4 Previous Clinical Trials

610 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many distinct settings is this medical study being conducted?

"The ongoing medical study is operational in four different sites. These include Houston, Austin, and Fairfax among other undisclosed locations. Opting for the site nearest to you can help reduce travel inconvenience while taking part in this trial."

Answered by AI

Are there any vacancies available for patients to participate in this trial?

"As per the details available on clinicaltrials.gov, this research is currently seeking suitable participants. The initial posting of this study was on August 30th, 2023, and the latest update was made on February 13th, 2024."

Answered by AI

What is the overall participant count in this clinical study?

"To proceed with the research, we need precisely 77 eligible participants. Pliant Therapeutics, Inc., the sponsor of this trial, will oversee operations at multiple locations such as University of Texas MD Anderson Cancer Center in Houston, Texas and NEXT Austin in Austin, Virginia."

Answered by AI

What is the risk level associated with Part 1 Dose Escalation: PLN-101095 administered on its own and in conjunction with Pembrolizumab for individuals?

"The safety rating for Part 1 Dose Escalation: PLN-101095 administered alone and with Pembrolizumab is a level 1 as per our assessment at Power. This evaluation is influenced by the early-stage nature of the trial, indicating minimal available data on both safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06270706.

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