PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with pemetrexed and platinum as first line treatment for MPM.
PD-L1 and VEGF play important roles in immune escape and tumor angiogenesis and enhance cancer growth and metastasis. PM8002 is a bispecific antibody targeting PD-L1 and VEGF-A. Here, the investigators present the results from a Phase II study of PM8002 in combination with pemetrexed and platinum subjects in unresectable malignant mesothelioma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Chinese PLA General Hospital
Beijing, China
Peking Cancer Hospital
Beijing, China
Objective Response Rate
Objective response rate (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
Treatment related adverse events (TRAEs)
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0.
Time frame: Up to 30 days after last treatment]
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
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
Progression free survival (PFS)
PFS 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).
Time frame: Up to approximately 2 years
Overall survival (OS)
OS is the time from the date of first dosing date to death due to any cause.
Time frame: Up to approximately 2 years
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IV infusion
Jilin Provincial Tumor Hospital
Changchun, China
Chongqing University Cancer Hospital
Chongqing, China
Liaoning Cancer Hospital and Institute
Dalian, China
Fujian Cancer Hospital
Fuzhou, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Zhejiang Provincial People's Hospital
Hangzhou, China
...and 6 more locations