Phase Ib/IIa Safety and Efficacy of PM8002, a Bispecific Antibody Targeting PD-L1 and VEGF-A, as a Monotherapy in Patients With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- PM8002
- Conditions
- Malignant Neoplasm
- Sponsor
- Biotheus Inc.
- Enrollment
- 380
- Locations
- 14
- Primary Endpoint
- Treatment related adverse events (TRAEs)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;
- •Male or female aged 18 to 75 years;
- •Patients with malignant tumor confirmed by histology or cytology;
- •The toxicity of previous anti-tumor therapy has not been alleviated；
- •Adequate organ function；
- •ECOG score was 0-1;
- •Expected survival \>=12 weeks;
- •According to RECIST 1.1 criteria, at least 1 measurable lesion that has not been previously treated locally.
Exclusion Criteria
- •History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study;
- •Evidence of major coagulopathy or other obvious risk of bleeding;
- •Patients are experiencing a clear interstitial lung disease or non-infectious pneumonia, unless it is caused by local radiotherapy;
- •Patients with uncontrolled brain metastases should be excluded from this clinical trial;
- •Patients ever experienced other active malignant tumors within 5 years prior to the study treatment;
- •Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
- •Syphilis antibody positive;
- •Patients with active tuberculosis (TB) are excluded;
- •Pregnant or lactating women;
Arms & Interventions
PM8002
PM8002 IV every 2 weeks(q2w) or every 3 weeks(q3w)
Intervention: PM8002
Outcomes
Primary Outcomes
Treatment related adverse events (TRAEs)
Time Frame: Up to 30 days after last treatment
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
Number of participants with DLTs
Time Frame: During the first three weeks of treatment with PM8002
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.
Objective response rate (ORR)
Time Frame: Up to approximately 2 years
Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
Secondary Outcomes
- Anti-drug antibody (ADA)(Up to 30 days after last treatment)
- Duration of response (DoR)(Up to approximately 2 years)
- Overall survival (OS)(Up to approximately 2 years)
- Progression-free survival (PFS)(Up to approximately 2 years)
- Disease control rate (DCR)(Up to approximately 2 years)