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.
Voluntarily signs the informed consent form.
Aged between 18 and 80 years (inclusive) at the time of consent; no gender restriction.
Histologically confirmed unresectable locally advanced or metastatic colorectal cancer.
At least one measurable target lesion according to RECIST v1.1.
Known history of severe allergic reactions to iparomlimab and tuvonralimab or bevacizumab.
Active malignancy other than colorectal cancer within 5 years prior to first treatment.
Large tumor lesions, especially those previously irradiated, with signs of bleeding.
Imaging showing tumor invasion of major blood vessels (e.g., pulmonary artery or superior vena cava), including encasement or invasion of the vessel lumen.
Single group
QL1706
DrugQL1706 (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
DrugBevacizumab is administered at a dose of 7.5 mg/kg every 3 weeks (Q3W) via intravenous (iv) infusion.
ORR
The proportion of subjects with complete response (CR) and partial response (PR) according RESIST1.1 in total subjects
DCR
The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD) in total subjects
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.
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).
6/12/24 PFS rate
6/12/24 months survival rate based on PFS Kaplan-Meier curve
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Qianfoshan Hospital
Lead sponsor
Linyi Tumour Hospital
Collaborator
Shandong Provincial Hospital
Collaborator
Qingdao Central Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
