This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of AK112 with or without AK117 in participants with metastatic colorectal cancer who are not suitable for surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
254
AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity
AK117 via intravenous (IV) infusion until disease progression or unacceptable toxicity
Oxaliplatin via IV infusion
Summit Therapeutics Research Site
Los Angeles, California, United States
Summit Therapeutics Research Site
Murrieta, California, United States
Summit Therapeutics Research Site
Fairfax, Virginia, United States
The Sixth Hospital,Sun Yat-sen University
Guanzhou, Guangdong, China
Objective response rates (ORR)
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1
Time frame: Up to approximately 2 years
Number of participants with adverse events (AEs)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: Up to approximately 2 years
Disease control rate (DCR)
Disease control rate (DCR) is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST V1.1
Time frame: Up to approximately 2 years
Duration of response (DOR)
DOR is defined for participants who had an objective response as the time from the first occurrence of a documented confirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause,whichever occurred first
Time frame: Up to approximately 2 years
Time to response (TTR)
TTR is defined for participants who had an objective response as the time from the start of treatment to the first occurrence of a documented unconfirmed response (CR or PR) .
Time frame: Up to approximately 2 years
Progression-free survival (PFS)
PFS is defined as the time from the start of treatment till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).
Time frame: Up to approximately 2 years
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Capecitabine via oral,The total daily dose was 2000mg/sqm, Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days
Irinotecan via IV infusion
Leucovorin via IV infusion
5-fluorouracil via IV infusion
Progression-free survival 2 (PFS2)
PFS 2 is defined as the time from the start of treatment till the second documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).
Time frame: Up to approximately 2 years
Overall survival (OS)
Overall survival is defined as the time from the start of treatment until death due to any cause.
Time frame: Up to approximately 2 years