This first-in-human open-label, multicenter, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and primary efficacy of IBI321 in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Several dose levels will be evaluated for IBI321 administered as a single agent. IBI321 will be given via IV infusion on Day 1 of each cycle until disease progression or loss of clinical benefit.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: From Day 1 of Cycle 1 to Day 28
Percentage of Participants with Adverse Events (AEs), treatment-related AE (TRAE), immune-related AEs (irAE) and serious adverse event (SAE) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Time frame: From Day 1 to up to 2 years
Objective Response Rate (ORR)per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Time frame: From Baseline until disease progression (up to 2 years)
Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Time frame: From Baseline until disease progression (up to 2 years)
Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Time frame: From Baseline until disease progression (up to 2 years)
Overall Survival (OS)
Time frame: From Baseline until disease progression (up to 2 years)
Area Under the Concentration-Time Curve (AUC) of IBI321
Time frame: From Day 1 up to 2 years
Maximum Serum Concentration (Cmax) of IBI321
Time frame: From Day 1 up to 2 years
Minimum Serum Concentration (Cmin) of IBI321
Time frame: From Day 1 up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clearance (CL) of IBI321
Time frame: From Day 1 up to 2 years
Percentage of Participants with Anti-Drug Antibodies (ADAs) and Neutralizing Antibody (Nab) to IBI321
Time frame: From Day 1 up to 2 years