This is a Phase I open-label, multi-center study of zamzetoclax (formerly GS-9716) tested either as monotherapy or in combination with other anti-cancer agents in patients with advanced solid malignancies. Primary objectives are to define the maximum tolerated dose (MTD) or maximum administered dose of zamzetoclax, and characterize the safety and tolerability of zamzetoclax as monotherapy and in combination with anti-cancer therapies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
145
Tablet(s) administered orally
Administered intravenously
Administered intravenously
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, United States
Moffitt Cancer Center
Tampa, Florida, United States
START Midwest
Grand Rapids, Michigan, United States
Montefiore Medial Center - Montefiore Medical Park
The Bronx, New York, United States
Novant Health Cancer Institute - Elizabeth (Breast Cancer)
Charlotte, North Carolina, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Oregon Health Oregon Health & Sciences University-Knight Cancer Institute
Portland, Oregon, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
START San Antonio
San Antonio, Texas, United States
START Mountain Region
West Valley City, Utah, United States
...and 3 more locations
Percentage of Patients Experiencing Dose-Limiting Toxicities (DLTs)
Time frame: First dose date up to 28 days
Percentage of Patients Experiencing Adverse Events (AEs) According to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), Version 5.0
Time frame: First dose date up to last dose date (Maximum: 105 weeks) plus 30 days
Maximum Observed Concentration (Cmax) for Zamzetoclax
Time frame: Approximately 105 Weeks
Time to Maximum Observed Concentration (Tmax) for Zamzetoclax
Time frame: Approximately 105 Weeks
Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) for Zamzetoclax
Time frame: Approximately 105 Weeks
Parts B and C: Objective Response Rate (ORR)
ORR is defined as the percentage of patients who achieve a confirmed complete response (CR) or confirmed partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Up to 105 weeks
Parts B and C: Disease Control Rate (DCR)
DCR is defined as the percentage of patients who achieve a CR, PR, or stable disease (SD) as assessed by RECIST version 1.1.
Time frame: Up to 105 weeks
Parts B and C: Progression-Free Survival (PFS)
PFS is defined as the interval from the first dose of zamzetoclax to the earlier of the first documentation of definitive progressive disease (PD) or death from any cause.
Time frame: First dose date to PD or death, whichever occurs first (up to 39 months)
Parts B and C: Time to Response (TTR)
TTR is defined as the time from first dose of zamzetoclax to the first documentation of CR or PR.
Time frame: First dose date to the first documentation of CR or PR (up to 105 weeks)
Parts B and C: Duration of Response (DOR)
DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death from any cause.
Time frame: From first documentation of CR or PR to PD or death, whichever occurs first (up to 37 months)
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