Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA)
Start Date
6/30/2023
Completion Date
9/30/2028
Summary
This interventional study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART6043 as monotherapy or in combination with olaparib.
Detailed Description
ART6043 is being developed as an oral anti-cancer agent in combination with a poly (adenosine diphosphate ribose) polymerase (PARP) inhibitor (PARPi) in patients with cancers that harbor defects in DNA repair. The study will consist of two parts: 1. Part A (Dose-escalation phase): Part A will evaluate ART6043 as monotherapy (Part A1) in patients with advanced or metastatic cancer and in combination with olaparib (Part A2), in patients with advanced or metastatic cancer with genetic lesions that cause loss of function of known DNA Damage Response (DDR) genes. Olaparib is also referred as PARPi. 2. Part B (dose-expansion phase): To further confirm the safety of ART6043 and assess its initial effectiveness in combination compared to olaparib alone (Part B2) in patients with a germline BRCA mutation who have HER2-ve advanced or metastatic breast cancer Patients may continue to receive ART6043 and/or olaparib as long as they may be continuing to derive clinical benefit as assessed by the investigator and/or until disease progression, withdrawal of consent or until they experience unacceptable drug-related toxicity.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
ART6043
Olaparib
Conditions
Locations
South Texas Accelerated Research Therapeutics (START) - Midwest
Grand Rapids, Michigan 49546
United States
Memorial Sloan-Kettering Cancer Center (MSKCC)
New York, New York 10065-6800
United States
Stephenson Cancer Center - Oncology
Oklahoma City, Oklahoma 73104
United States
Jefferson University Hospitals - Kimmel Cancer Center
Philadelphia, Pennsylvania 17107
United States
SCRI oncology partners
Nashville, Tennessee 37203
United States
Mary Crowley Cancer Center - Clinic
Dallas, Texas 75251
United States
The University of Texas - MD Anderson Cancer Center
Houston, Texas 77030
United States
Hospital Universitario Clínico San Cecilio
Granada, Andalusia 18007
Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Castille and León 47003
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia 08025
Spain
Hospital San Pedro de Alcántara
Cáceres, Extremadura 10003
Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid 28041
Spain