A Phase 1 study of IBI363 in combination with Bevacizumab or Furuitinib in Subjects with Advanced Colorectal Cancer
Sign written informed consent and be able to comply with the program's visit schedule and related procedures.
Male or female subjects, age 18~75 years.
Histologically or cytologically confirmed advanced colorectal cancer.
Subjects who have progressed on standard therapy, who are unsuitable for standard therapy, who do not have standard therapy, or who have refused standard therapy.
Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug.
Active epileptic seizures or active central nervous system (CNS ) metastases and so on.
Clinically significant cardiovascular or cerebrovascular disease.
Interstitial pneumonia, pulmonary fibrosis, pneumoconiosis, drug-associated pneumonia, and radiation pneumonitis requiring steroid hormone or other therapy, as well as history of severe abnormal lung function or other forms of restrictive lung disease.
Factorial
IBI363 combined with Bevacizumab
DrugIBI363 will be administrated on Day 1 of every 2 weeks or every 3 weeks, intravenous injection. Bevacizumab, intravenous injection.
IBI363 + Furuitinib
DrugIBI363 Q2W or Q3W IV，Furuitinib po
Adverse Event (AE), Treatment-Emergent AE (TEAE), Adverse Event of Special Interest (AESI) and Serious Adverse Event (SAE)
Adverse events will be assessed by investigator(s) according to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0).
Objective response rate (ORR)
The efficacy of solid tumors was evaluated according to Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1).
Time to response (TTR)
The efficacy of solid tumors was evaluated according to RECIST v1.1
disease control rate (DCR)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Duration of response (DoR)
The efficacy of solid tumors was evaluated according to RECIST v1.1
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