PM8002 in the Treatment of Patients With Advanced Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Malignant Neoplasm

In brief

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.

Key facts

Study ID

NCT05918445

Run by

Biotheus Inc.

People needed

380

Starts

2021-03-09

Expected to finish

2025-11-30

Last updated by the study team

2024-12-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Baoji Central Hospital — Baoji, China (enrolling)
• Baoji Central Hospital — Baoji, China (enrolling)
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, China (enrolling)
• Peking University Cancer Hospital — Beijing, China (enrolling)
• Peking University Cancer Hospital — Beijing, China (enrolling)
• Jilin Cancer Hospital — Changchun, China (enrolling)
• The First Hospital of Jilin University — Changchun, China (enrolling)
• Changde First People's Hospital — Changde, China (enrolling)
• Hunan Provincial People's Hospital — Changsha, China (enrolling)
• The First People's Hospital of Changzhou — Changzhou, China (enrolling)
• Chengdu Integrated TCM& Western Medicine Hospital — Chengdu, China (enrolling)
• Sichuan Cancer Hospital — Chengdu, China (enrolling)
• Chongqing Cancer Hospital — Chongqing, China (enrolling)
• Chongqing Cancer Hospital — Chongqing, China (enrolling)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, China (enrolling)
• The Southwest Hospital of AMU — Chongqing, China (enrolling)
• Fujian Cancer Hospital — Fuzhou, China (enrolling)
• Fujian Cancer Hospital — Fuzhou, China (enrolling)
• Zhejiang Provincial People's Hospital — Hangzhou, China (enrolling)
• Harbin Medical University Cancer Hospital — Harbin, China (enrolling)
• Anhui Provincial Hospital — Hefei, China (enrolling)
• Linyi Cancer Hospital — Linyi, China (enrolling)
• Jiangsu Province Hospital — Nanjing, China (enrolling)
• Jiangsu Province Hospital — Nanjing, China (enrolling)
• Shanghai Orient Hospital — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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