RecruitingPhase 1Phase 2NCT05918445
PM8002 in the Treatment of Patients With Advanced Solid Tumors
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
Sponsor
Biotheus Inc.
Enrollment
380 participants
Start Date
Mar 9, 2021
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria8
- 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 Criteria11
- 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;
- Other conditions lead to inappropriate to participate in this study as judged by the investigator.
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Interventions
DRUGPM8002
IV infusion
Locations(48)
View Full Details on ClinicalTrials.gov
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NCT05918445
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