PM8002 (BNT327) is a bispecific antibody targeting PD-L1 and VEGF. This is a phase II trial to evaluate the efficacy and safety of PM8002 in combination with chemotherapy in first line MSS or MSI-L/pMMR metastatic colorectal cancer.
A multicenter, randomized, open-label study design is used, with a planned enrollment of 100 participants, 40 in the PM8002 (BNT327)+ chemotherapy regimen 1 group, 30 in the PM8002 (BNT327)+ chemotherapy regimen 2 group and 30 in the PM8002 (BNT327)+ chemotherapy regimen 3 group. The investigators make the decision on which chemotherapy regimen to be used in the participants. After combined chemotherapy regimen is confirmed, participants will be randomized to one of two dose levels of PM8002(BNT327) plus chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGObjective response rate (ORR)
Objective response rate 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
Occurrence and severity of TEAE (treatment emergent adverse event), TRAE(treatment related adverse event), TESAE (treatment emergent serious adverse event), TRSAE (treatment related serious adverse event)
AEs are graded according to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 in the combination treatment regimen.
Time frame: From the first dose of the investigational medicinal product (IMP) to the 30-day Safety Follow-Up Visit
Duration of response (DoR)
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Disease control rate (DCR)
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
Time to response (TTR)
TTR is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieve CR or PR (based on RECIST v1.1).
Time frame: Up to approximately 2 years
Progression free survival (PFS)
Progression free survival is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1).
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IV infusion
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RECRUITINGHubei Cancer Hospital
Wuhan, Hubei, China
RECRUITINGJilin Cancer Hospital
Changchun, Jilin, China
RECRUITINGCancer Hospital of Shandong First Medical University
Jinan, Shandong, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGXinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGSichuan Cancer Hospital
Chengdu, Sichuan, China
RECRUITING...and 1 more locations
Time frame: Up to approximately 2 years
Overall survival (OS)
OS is the time from the date of randomization or first dosing date to death due to any cause.
Time frame: Up to approximately 5 years