This phase 1 open-label study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of CHS-006 in combination with toripalimab in 2 phases. Phase 1 (Dose Optimization phase) will explore 2 different dose combinations in participants with advanced/metastatic solid tumors (except pancreatic) and Phase 2 (Indication-specific Expansion phase) will use one selected dose in specific tumor types (non-small cell lung cancer-non squamous \[NSCLC-NS\] and Hepatocellular carcinoma \[HCC\])
The Dose Optimization phase will enroll participants with advanced/metastatic solid tumors (except pancreatic). Up to 20 participants will be randomized into two dosing arms. Two different primary advanced solid tumors have been selected for investigation of antitumor activity in the Indication-specific Expansion phase. Up to 40 participants will be enrolled into each Indication-specific Expansion phase cohort. All participants in both phases will receive CHS-006 in combination with toripalimab intravenously (IV) every 3 weeks (Q3W).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Arm A participants will receive CHS-006 administered via IV Q3W.
Arm B participants will receive toripalimab administered via IV Q3W.
University of Florida Health Cancer Center
Orlando, Florida, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Renown Institute for Cancer
Reno, Nevada, United States
Gabrail Cancer and Research Center
Canton, Ohio, United States
Assessment of the number of participants with treatment-emergent adverse events (TEAEs) receiving CHS-006 administered in combination with toripalimab
Assessed by number of participants with TEAEs assessed by the investigator as per CTCAE v5.0.
Time frame: Day 1 of study treatment through up to 90 days post last dose of study treatment
Description of the PK profile of CHS-006 in combination with toripalimab
Assessed by serum concentration of CHS-006 and toripalimab as determined by validated assays
Time frame: Measured at multiple timepoints from Day 1 of study treatment through up to 90 days post last dose of study treatment
Immunogenicity of CHS-006 and/or toripalimab
Percentage of participants who develop treatment-emergent antidrug antibodies (ADA) to CHS-006 and/or toripalimab
Time frame: Measured at multiple timepoints from Day 1 of study treatment through up to 90 days post last dose of study treatment
Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessed by the investigator
Investigator-assessed ORR as per RECIST v1.1
Time frame: Measured at multiple timepoints from Day 1 of study treatment through +/- 7 days at the completion of or premature withdrawal from the study
Duration of response (DoR) using RECIST v1.1 assessed by the investigator
Investigator-assessed DoR as per RECIST v1.1
Time frame: Measured at multiple timepoints from Day 1 of study treatment through +/- 7 days at the completion of or premature withdrawal from the study
Disease control rate (DCR) using RECIST v1.1 assessed by the investigator
Investigator-assessed DCR as per RECIST v1.1
Time frame: Measured at multiple timepoints from Day 1 of study treatment through +/- 7 days at the completion of or premature withdrawal from the study
Time to response (TTR) using RECIST v1.1 assessed by the investigator
Investigator-assessed TTR as per RECIST v1.1
Time frame: Measured at multiple timepoints from Day 1 of study treatment through +/- 7 days at the completion of or premature withdrawal from the study
Progression-free survival (PFS) using RECIST v1.1 assessed by the investigator
Investigator-assessed PFS as per RECIST v1.1
Time frame: Measured at multiple timepoints from Day 1 of study treatment through +/- 7 days at the completion of or premature withdrawal from the study
Overall survival (OS) using RECIST v1.1 assessed by the investigator
Investigator-assessed PFS as per RECIST v1.1
Time frame: Measured at multiple timepoints from Day 1 of study treatment through +/- 7 days at the completion of or premature withdrawal from the study
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