Health Trials

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

ConditionAdvanced or Metastatic Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPliant Therapeutics, Inc.

About this trial

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

Eligibility criteria

Qualifiers

Has histologically or cytologically confirmed advanced or metastatic solid tumor

Have received ≥12 weeks of continuous anti-PD-1 or anti-PD-L1 treatment administered as monotherapy or in combination with other anticancer therapies

Have demonstrated documented prior clinical benefit, defined as CR or PR at any time during treatment, or SD lasting ≥6 months (Part 2 only)

Must have subsequently developed radiographic disease progression while receiving anti-PD-1 or anti-PD-L1 treatment or within ≤12 weeks after the last dose of such treatment

Disqualifiers

Any immune-related medical conditions that would put participants at greater risk when receiving pembrolizumab

Has a known additional malignancy that is progressing or has required active treatment within the past 2 years

Has received prior radiotherapy within 2 weeks for palliative bone-directed therapy and 4 weeks for all other radiotherapy

Has undergone major surgery within 4 weeks prior to the first dose of study treatment or has not adequately recovered from surgery or related complications

Trial design

Treatments tested in this trial

  • PLN-101095
  • PLN-101095
  • PLN-101095
  • PLN-101095
  • PLN-101095
  • PLN-101095
  • Pembrolizumab

Treatment groups

124 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Locations

6
Yale University06511, New HavenConnecticut, United States
Winship Cancer Institute of Emory University30322, AtlantaGeorgia, United States
South Texas Accelerated Research Therapeutics (START)49546, Grand RapidsMichigan, United States
NEXT Austin78758, AustinTexas, United States

Sponsors and collaborators

Pliant Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov