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)
Coherus Oncology, Inc.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * At least 1 measurable lesion based on RECIST v1.1 as determined by the Investigator. * Resolved acute effects of any prior therapy to baseline severity or Grade 1 in accordance with National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except for adverse events (AEs) not constituting a safety risk per Investigator judgement. Cohort A (2L Gastric, Gastro-esophageal-junction \[GEJ\], Esophageal Adenocarcinoma \[EAC\]) Specific Inclusion Criteria: * Histologically or cytologically documented unresectable, locally advanced or meta…
Interventions
- DrugCHS-114
Solution for infusion
- DrugToripalimab
Solution for infusion
- Drug5 Fluorouracil
Solution for infusion
- DrugCisplatin
Solution for infusion
Locations (30)
- The University of Arizona Cancer CenterTucson, Arizona
- City of HopeDuarte, California
- University of Colorado - Aurora Cancer CenterAurora, Colorado
- Winship Cancer Center - Emory UniversityAtlanta, Georgia
- Ochsner HealthNew Orleans, Louisiana
- Henry Ford Health SystemDetroit, Michigan