This is a single-arm, multi-center, exploratory study evaluating the efficacy and safety of iparomlimab and tuvonralimab (QL1706) in combination with bevacizumab for the treatment of patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) unresectable or metastatic colorectal cancer. Eligible participants who meet the inclusion and exclusion criteria will provide written informed consent and receive QL1706 at 5.0 mg/kg and bevacizumab at 7.5 mg/kg on Day 1 of every 3-week cycle (Q3W), until disease progression or completion of 2 years of treatment. The primary endpoint of this study is objective response rate (ORR). Secondary endpoints include disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), PFS and OS rates at 6, 12, and 24 months, and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
QL1706 (Iparomlimab and Tuvonralimab) is administered at a dose of 5 mg/kg via intravenous infusion on Day 1 of each 3-week cycle (Q3W).
Bevacizumab is administered at a dose of 7.5 mg/kg every 3 weeks (Q3W) via intravenous (iv) infusion.
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
ORR
The proportion of subjects with complete response (CR) and partial response (PR) according RESIST1.1 in total subjects
Time frame: approximately 6 months after the last subject participating in
DCR
The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD) in total subjects
Time frame: approximately 12 months after the last subject participating in
DOR
The time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.
Time frame: approximately 12 months after the last subject participating in
PFS
The time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first (per RECIST 1.1).
Time frame: approximately 12 months after the last subject participating in
6/12/24 PFS rate
6/12/24 months survival rate based on PFS Kaplan-Meier curve
Time frame: 6/12/24 months after the last subject participating in
OS
The time from the starting date of study drug to the date of death due to any cause.
Time frame: approximately 12 months after the last subject participating in
6/12/24 OS rate
6/12/24 months survival rate based on OS Kaplan-Meier curve
Time frame: 6/12/24 months after the last subject participating in
Safety (adverse event)
The rates of adverse events based on NCI CTCAE v5.0
Time frame: Up to approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.