Spots Global Cancer Trial Database for PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 Mutation
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Trial Identification
Brief Title: PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 Mutation
Official Title: A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT3789 as Monotherapy and in Combination With Docetaxel in Participants With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation
Study ID: NCT05639751
Study Description
Brief Summary: This is a Phase 1 dose-escalation study of PRT3789, a SMARCA2 degrader, in participants with advanced or metastatic solid tumors with loss of SMARCA4 due to truncating mutation and/or deletion. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of PRT3789 monotherapy and in combination with docetaxel, describe any dose limiting toxicities (DLTs), define the dosing schedule, and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) to be used in subsequent development of PRT3789.
Detailed Description: This is an open-label, multi-center, dose-escalation, first in human, Phase 1 study of PRT3789 as monotherapy and in combination with docetaxel, a SMARCA2 degrader, evaluating participants with advanced or metastatic solid tumors with loss of SMARCA4 due to truncating mutation and/or deletion. The study will evaluate escalating doses of PRT3789 until the MTD or RP2D is determined. Taking into account pharmacokinetic and pharmacodynamic data from the preceding dose levels, the dose may be escalated until a dose limiting toxicity is identified. Approximately 118 participants will be enrolled in monotherapy, dose escalation, backfill, and combination cohorts.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California, Davis Comprehensive Cancer Center, Sacramento, California, United States
UCLA Hematology/Oncology - Santa Monica, Santa Monica, California, United States
Smilow Cancer Hospital Phase 1 Unit, New Haven, Connecticut, United States
AdventHealth Medical Group Oncology Research at Celebration, Celebration, Florida, United States
Winship Cancer Institute, Atlanta, Georgia, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Washington University School of Medicine - Siteman Cancer Center, Saint Louis, Missouri, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York, United States
New York Presbyterian Hospital - Columbia University Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
NEXT Virginia, Fairfax, Virginia, United States
lnstitut Bergonie Centre Regionale de Lutte Contre le cancer, Service Oncologie-Medicale, Bordeaux, , France
Centre Leon Berard, Lyon Cedex 08, , France
Institut Gustave Roussy, Villejuif Cedex, , France
Leids Universitair Medisch Centrum, Leiden, , Netherlands
National University Hospital, Singapore, , Singapore
National Cancer Centre Singapore, Singapore, , Singapore
START Barcelona - HM Nou Delfos, Barcelona, , Spain
START MADRID - FJD Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Contact Details
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