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.
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.
Histologically or cytologically documented unresectable, locally advanced or metastatic gastric, GEJ, or esophageal adenocarcinoma that is human epidermal growth factor receptor 2 (HER2) - negative and microsatellite stable (MSS)/proficient mismatch repair (pMMR).
Progressed during or after first line systemic therapy that includes a platinum and fluoropyrimidine doublet with or without anti-programmed death receptor 1 (PD-1)/programmed death ligand 1 (PD-L1)-directed therapy (that is, in the second line setting).
History of prior malignancy other than the cancer under study that is progressing or has required active treatment within the past 3 years.
Symptomatic or untreated central nervous system metastases, including leptomeningeal metastases, requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids.
Major surgery requiring general anesthesia within 28 days prior to the first dose of study treatment, still recovering from prior surgery, or with surgery scheduled during the study.
Prior exposure to anti-C-C motif chemokine receptor 8 (CCR8) antibody.
Parallel
CHS-114
DrugSolution for infusion
Toripalimab
DrugSolution for infusion
5 Fluorouracil
DrugSolution for infusion
Cisplatin
DrugSolution for infusion
7
Treatment groupsSee each treatment group below.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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.
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.
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.
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).
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