A Phase 1B, Multicenter, Open-Label Study of the Safety and Efficacy of CHS-114 in Combination With Toripalimab With or Without Other Treatments in Participants With Advanced or Metastatic Solid Tumors (TREGCHECK 102)
Summary
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.
Arms & interventions
- DrugCHS-114
Solution for infusion
- DrugToripalimab
Solution for infusion
- Drug5 Fluorouracil
Solution for infusion
- DrugCisplatin
Solution for infusion
Outcome measures
Primary
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)
Secondary
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Investigator Assessment
Time frame: Up to approximately 2.25 years
Duration of Response (DOR) Per RECIST v1.1 Based on Investigator Assessment
Time frame: Up to approximately 2.25 years
Disease Control Rate (DCR) Per RECIST v1.1 Based on Investigator Assessment
Time frame: Up to approximately 2.25 years
Progression-free Survival (PFS) Per RECIST v1.1 Based on Investigator Assessment
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
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
Eligibility criteria
Study locations (20)
The University of Arizona Cancer Center
Tucson, Arizona, 85724
City of Hope
Duarte, California, 91010
University of Colorado - Aurora Cancer Center
Aurora, Colorado, 80045
Winship Cancer Center - Emory University
Atlanta, Georgia, 30322
Ochsner Health
New Orleans, Louisiana, 70121
Henry Ford Health System
Detroit, Michigan, 48202
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, 89169
Christus St Vincent Regional Medical Center
Santa Fe, New Mexico, 87505
START New York
Lake Success, New York, 11042
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Icahn School of Medicine at Mount Sinai
New York, New York, 11766
University of Pittsburg Medical Center _UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Prisma Health Cancer Institute
Greenville, South Carolina, 29605
SCRI Oncology Partners
Nashville, Tennessee, 37203
Texas Oncology - Central South
Austin, Texas, 78731
START San Antonio, LLC.
San Antonio, Texas, 78229
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
START Mountain Region, LLC.
West Valley City, Utah, 84119
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Virginia Oncology Associates
Norfolk, Virginia, 23502
References
- Wang X, Kapoor VN, Chin DJ, Klakamp SL, Baruffaldi F, Mohan JF, Haines R, Dulak A, Panduro M, Ren Y, Masia R, Hill JA, LaVallee TM, Rajasekaran N. CHS-114: An Afucosylated Anti-CCR8 Monoclonal Antibody that Selectively Depletes Intratumoral Treg Cells and Induces Antitumor Immune Responses. Mol Cancer Ther. 2026 May 4;25(5):685-700. doi: 10.1158/1535-7163.MCT-25-0367.(PubMed)