Recruiting
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
What is being tested
PM8002
Drug
Who is being recruted
Neoplasms
From 18 to 75 Years
+19 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1 & 2
Interventional
Study Start: March 2021
Summary
Principal SponsorBiotheus Inc.
Study ContactYe Guo
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Study start date: March 9, 2021
Actual date on which the first participant was enrolled.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.
Official TitlePhase 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
Principal SponsorBiotheus Inc.
Study ContactYe Guo
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
380 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Neoplasms
Criteria
8 inclusion criteria required to participate
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；
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11 exclusion criteria prevent from participating
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;
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalPM8002 IV every 2 weeks(q2w) or every 3 weeks(q3w)
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 48 locations
Recruiting
Recruiting
Shanghai Sixth People's Hospital
Shanghai, ChinaRecruiting
Shengjing Hospital of China Medical University
Shengjing, ChinaRecruiting
Liaoning Cancer Hospital
Shenyang, ChinaRecruiting
48 Study Centers