A Phase 1 study of IBI363 in combination with Bevacizumab or Furuitinib in Subjects with Advanced Colorectal Cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
260
IBI363 will be administrated on Day 1 of every 2 weeks or every 3 weeks, intravenous injection. Bevacizumab, intravenous injection.
IBI363 Q2W or Q3W IV,Furuitinib po
Union Hospital, Tongji Medical College, Huazhong University Hospital
Wuhan, Hubei, China
RECRUITINGAdverse 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).
Time frame: Through out the study (up to 2 years)
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 frame: Through out the study (up to 2 years)
Time to response (TTR)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Time frame: Through out the study (up to 2 years)
disease control rate (DCR)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Time frame: Through out the study (up to 2 years)
Duration of response (DoR)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Time frame: Through out the study (up to 2 years)
Progression-free survival (PFS)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Time frame: Through out the study (up to 2 years)
Overall survival (OS)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Time frame: Through out the study (up to 2 years)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.