The main purpose of this study is to evaluate the safety and preliminary efficacy of CHS-114 in combination with toripalimab and/or other standard of care (SOC) compound(s) in participants with advanced or metastatic solid tumors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
154
Solution for infusion
Solution for infusion
Solution for infusion
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug until 90 days after the last dose of study drug (up to approximately 2.25 years)
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Investigator Assessment
ORR is defined as percentage of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1.
Time frame: Up to approximately 2.25 years
Duration of Response (DOR) Per RECIST v1.1 Based on Investigator Assessment
DOR is defined as the time from first documentation of response (CR or PR) to first radiographic documentation of progressive disease or death due to any cause according to RECIST v1.1.
Time frame: Up to approximately 2.25 years
Disease Control Rate (DCR) Per RECIST v1.1 Based on Investigator Assessment
DCR is defined as the percentage of participants who achieve a confirmed CR or PR or stable disease (SD) lasting ≥ 12 weeks according to RECIST v1.1.
Time frame: Up to approximately 2.25 years
Progression-free Survival (PFS) Per RECIST v1.1 Based on Investigator Assessment
PFS is defined as the time of the first dose of study treatment to the time of the first documented unequivocal disease progression assessed per RECIST v1.1 or death due to any cause (whichever occurs first).
Time frame: Up to approximately 2.25 years
Landmark PFS Rates
Time frame: Months 6, 9, and 12
Maximum Observed Serum Concentration (Cmax) of CHS-114
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Solution for infusion
The University of Arizona Cancer Center
Tucson, Arizona, United States
RECRUITINGCity of Hope
Duarte, California, United States
RECRUITINGUniversity of Colorado - Aurora Cancer Center
Aurora, Colorado, United States
RECRUITINGWinship Cancer Center - Emory University
Atlanta, Georgia, United States
RECRUITINGOchsner Health
New Orleans, Louisiana, United States
RECRUITINGHenry Ford Health System
Detroit, Michigan, United States
RECRUITINGComprehensive Cancer Center of Nevada
Las Vegas, Nevada, United States
RECRUITINGChristus St Vincent Regional Medical Center
Santa Fe, New Mexico, United States
RECRUITINGSTART New York
Lake Success, New York, United States
RECRUITINGDavid H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITING...and 16 more locations
Time frame: Up to approximately 2.25 years (pre-infusion and up to 336 hours post-infusion)
Time to Reach Cmax (Tmax) of CHS-114
Time frame: Up to approximately 2.25 years (pre-infusion and up to 336 hours post-infusion)
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of CHS-114
Time frame: Up to approximately 2.25 years (pre-infusion and up to 336 hours post-infusion)
Number of Participants With Anti-drug Antibodies (ADAs)
Time frame: Up to approximately 2.25 years