A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
- Registration Number
- NCT06270706
- Lead Sponsor
- Pliant Therapeutics, Inc.
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 77
- Has histologically or cytologically confirmed advanced solid tumor
- Has an advanced or metastatic solid tumor (for which pembrolizumab is indicated) and have evidence of disease progression after treatment with pembrolizumab.
- At least 1 measurable lesion, as defined by RECIST v1.1
- Estimated survival of ≥3 months
- 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)
- Any immune-related medical conditions that would put participants at greater risk when receiving pembrolizumab
- Previous treatment with pembrolizumab <21 days prior to the first dose of combination therapy of pembrolizumab and PLN-101095
- Received an immunotherapy other than pembrolizumab in the last 4 weeks prior to the first dose of PLN-101095
- 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
- Received chemotherapy or other targeted therapies within 2 weeks prior to the first dose of PLN-101095
- Received a cell therapy within the last 12 months prior to the first dose of PLN-101095
- Known active central nervous system (CNS) metastases (brain and/or leptomeningeal metastases)
- Pregnant or lactating female participant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1 Dose Escalation: PLN-101095 given as monotherapy and in combination with Pembrolizumab Pembrolizumab - Part 2 Dose Expansion: PLN-101095 in combination with Pembrolizumab Pembrolizumab - Part 1 Dose Escalation: PLN-101095 given as monotherapy and in combination with Pembrolizumab PLN-101095 - Part 2 Dose Expansion: PLN-101095 in combination with Pembrolizumab PLN-101095 -
- Primary Outcome Measures
Name Time Method Proportion of participants with treatment-emergent adverse events and serious adverse events per CTCAE Version 5.0. 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. First dose to 35 days
- Secondary Outcome Measures
Name Time Method Time to maximum observed concentration (Tmax) to characterize the plasma pharmacokinetics (PK). First dose until 10 weeks Area under the concentration-time curve over a dosing interval (AUC0-τ) to characterize the plasma pharmacokinetics (PK). 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. 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. Day 1 until end of study treatment regimen Maximum observed plasma concentration (Cmax) to characterize the plasma pharmacokinetics (PK). First dose until 10 weeks
Trial Locations
- Locations (5)
South Texas Accelerated Research Therapeutics (START)
🇺🇸Grand Rapids, Michigan, United States
NEXT Virginia
🇺🇸Fairfax, Virginia, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Yale University
🇺🇸New Haven, Connecticut, United States
NEXT Austin
🇺🇸Austin, Texas, United States