This study is a phase II study to evaluate the efficacy, safety and tolerability of HLX26 and HLX10 in the treatment of patients with metastatic colorectal carcinoma that had received 3 prior therapies.
This study is a phase II study to evaluate the efficacy, safety and tolerability of HLX26 and HLX10 in the treatment of patients with metastatic colorectal carcinoma that had received 3 prior therapies. The study is composed of the first stage (escalation stage) and the second stage (expansion stage). In the first stage (escalation stage), a 3 + 3 dose escalation design will be used. Patients will receive 3 dose levels of HLX26 (500mg, 800mg, 1600mg) combined with HLX10 300mg intravenously every 3 weeks. Observation period of DLT lasts for 3 weeks after the first administration of HLX26. In the second stage, the safety and efficacy of 2 dose levels of HLX26 (800mg and 1600mg) combined with HLX10 300mg will be evaluated. Eligible subjects will be enrolled in the HLX26 800mg group and HLX26 1600mg group in sequence, 20 subjects per group.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Dose-limiting toxicity (DLT) (the first stage)
The DLT of HLX26 in combination with HLX10 within 3 weeks after the first administration in patients with metastatic colorectal carcinoma.
Time frame: from day1 to day 21
Maximum Tolerated Dose (MTD) (the first stage)
The MTD of HLX26 in combination with HLX10 within 3 weeks after the first administration in patients with metastatic colorectal carcinoma.
Time frame: from day1 to day 21
Objective Response Rate (ORR) per RECIST 1.1 as Assessed by Investigator (the second stage)
The ORR is defined as the percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by investigator.
Time frame: approximately up to 6 months
Overall Survival (OS)
OS is defined as the time from first dose to death due to any cause.
Time frame: approximately up to 24 months
Progression-Free Survival (PFS) per RECIST 1.1 assessed by Investigator
PFS is defined as the time from first dose to the first documented disease progression per RECIST 1.1 by investigator or death due to any cause, whichever occurs first.
Time frame: approximately up to 24 months
Duration of Response (DOR) per RECIST 1.1 assessed by Investigator
DOR is defined as the time from the first documented CR or PR until disease progression or death due to any cause, whichever occurs first. DOR is only for participants who demonstrate confirmed ORR.
Time frame: approximately up to 6 months
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