A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
Start Date
8/30/2023
Completion Date
6/1/2030
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 with accelerated titration * Part 2: Dose-expansion cohorts using Simon's 2-stage design
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
PLN-101095
PLN-101095
PLN-101095
PLN-101095
PLN-101095
PLN-101095
Pembrolizumab
Conditions
Locations
Yale University
New Haven, Connecticut 06511
United States
Winship Cancer Institute of Emory University
Atlanta, Georgia 30322
United States
South Texas Accelerated Research Therapeutics (START)
Grand Rapids, Michigan 49546
United States
Washington University Medicine
St Louis, Missouri 63110
United States
START New Jersey
East Brunswick, New Jersey 08816
United States
START New York Long Island LLC
Lake Success, New York 11042
United States
Carolina Cancer Research Center
Wilson, North Carolina 27893
United States
Avera Medical Group
Sioux Falls, South Dakota 57105
United States
Tennessee Oncology
Nashville, Tennessee 37203
United States
NEXT Austin
Austin, Texas 78758
United States
START Center for Clinical Research
Fort Worth, Texas 76104
United States
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
NEXT Houston
Houston, Texas 77054
United States
START Mountain Region
West Valley City, Utah 84119
United States
Inova Schar Cancer Institute
Fairfax, Virginia 22031
United States
NEXT Virginia
Fairfax, Virginia 22031
United States
Hospital Universitari Quirónsalud (NEXT Barcelona)
Barcelona, Barcelona 08023
Spain
START Barcelona - Hospital HM Nou Delfos
Barcelona, Barcelona 08023
Spain
START Center for Cancer Research - La Rioja
Logroño, La Rioja 26006
Spain
START Madrid - Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid 28040
Spain
START Madrid - Centro Integral Oncológico Clara Campal
Madrid, Madrid 28050
Spain
University Hospital Quironsalud Madrid (NEXT Madrid)
Madrid, Pozuelo de Alarcón 28223
Spain