This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of PM8002, a PD-L1/VEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
380
IV infusion
Number of participants with DLTs
DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle (3weeks) of treatment.
Time frame: During the first three weeks of treatment with PM8002
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
Objective response rate (ORR)
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
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). for subjects with no documented disease progression, the deadline is the data of the last examination.
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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Baoji Central Hospital
Baoji, China
RECRUITINGBaoji Central Hospital
Baoji, China
RECRUITINGCancer Hospital Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGPeking University Cancer Hospital
Beijing, China
RECRUITINGPeking University Cancer Hospital
Beijing, China
RECRUITINGJilin Cancer Hospital
Changchun, China
RECRUITINGThe First Hospital of Jilin University
Changchun, China
RECRUITINGChangde First People's Hospital
Changde, China
RECRUITINGHunan Provincial People's Hospital
Changsha, China
RECRUITINGThe First People's Hospital of Changzhou
Changzhou, China
RECRUITING...and 38 more locations
Progression-free survival (PFS)
Progression-free survival is defined as the time from the start of treatment with PM8002 until the first documentation of disease progression or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Anti-drug antibody (ADA)
To evaluate the incidence of ADA to PM8002.
Time frame: Up to 30 days after last treatment