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Recruiting Phase 1, Phase 2 NCT05918445

PM8002 in the Treatment of Patients With Advanced Solid Tumors

Trial Parameters

Condition Malignant Neoplasm
Sponsor Biotheus Inc.
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 380
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2021-03-09
Completion 2025-11-30
Interventions
PM8002

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.

Eligibility Criteria

Inclusion Criteria: 1. Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures; 2. Male or female aged 18 to 75 years; 3. Patients with malignant tumor confirmed by histology or cytology; 4. The toxicity of previous anti-tumor therapy has not been alleviated; 5. Adequate organ function; 6. ECOG score was 0-1; 7. Expected survival \>=12 weeks; 8. According to RECIST 1.1 criteria, at least 1 measurable lesion that has not been previously treated locally. Exclusion Criteria: 1. History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study; 2. Evidence of major coagulopathy or other obvious risk of bleeding; 3. Patients are experiencing a clear interstitial lung disease or non-infectious pneumonia, unless it is caused by local radiotherapy; 4. Patients with uncontrolled brain metastases should be excluded from this clinica

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