Treatment of advanced solid tumors with PM8002

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and anti-tumor activity of PM8002, a bispecific antibody targeting PD-L1 and VEGF, in adults with advanced solid tumors. Participants will receive PM8002 as a single agent, and the study aims to gather comprehensive data on its effects and potential benefits. The trial includes both Phase 1 and Phase 2 assessments to ensure thorough evaluation of the treatment's impact.

Why it matters

Who can join: the full rules

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 clinical trial;
5. Patients ever experienced other active malignant tumors within 5 years prior to the study treatment;
6. Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
7. Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
8. Syphilis antibody positive;
9. Patients with active tuberculosis (TB) are excluded;
10. Pregnant or lactating women;
11. Other conditions lead to inappropriate to participate in this study as judged by the investigator.

Where it's running

• Baoji Central Hospital
  Baoji, China Recruiting
• Baoji Central Hospital
  Baoji, China Recruiting
• Cancer Hospital Chinese Academy of Medical Sciences
  Beijing, China Recruiting
• Peking University Cancer Hospital
  Beijing, China Recruiting
• Peking University Cancer Hospital
  Beijing, China Recruiting
• Jilin Cancer Hospital
  Changchun, China Recruiting

Study contacts

• Principal investigator: Ye Guo — Shanghai Orient Hospital
• Study coordinator: Ye Guo
• Email: pattrickguo@gmail.com
• Phone: 135 0167 8472

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.