Treatment of advanced solid tumors with PM8002

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

This study is testing a new treatment called PM8002 to see if it can help adults with advanced solid tumors by targeting specific proteins that may help fight their cancer.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 380 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Biotheus Inc. (Industry-sponsored)
• Locations: 48 sites (Baoji and 47 other locations)
• Trial ID: NCT05918445 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with confirmed malignant tumors and measurable lesions who have not responded to prior therapies.

Not a fit: Patients with uncontrolled brain metastases or severe allergic reactions to the study drug may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.

How similar studies have performed: Other studies involving bispecific antibodies targeting PD-L1 and VEGF have shown promise, indicating potential for success in this approach.

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 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 this trial is running

Baoji and 47 other locations

• 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)
• The First Hospital of Jilin University — Changchun, China (Recruiting)
• Changde First People's Hospital — Changde, China (Recruiting)
• Hunan Provincial People's Hospital — Changsha, China (Recruiting)
• The First People's Hospital of Changzhou — Changzhou, China (Recruiting)
• Chengdu Integrated TCM& Western Medicine Hospital — Chengdu, China (Recruiting)
• Sichuan Cancer Hospital — Chengdu, China (Recruiting)
• Chongqing Cancer Hospital — Chongqing, China (Recruiting)
• Chongqing Cancer Hospital — Chongqing, China (Recruiting)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, China (Recruiting)
• The Southwest Hospital of AMU — Chongqing, China (Recruiting)
• Fujian Cancer Hospital — Fuzhou, China (Recruiting)
• Fujian Cancer Hospital — Fuzhou, China (Recruiting)
• Zhejiang Provincial People's Hospital — Hangzhou, China (Recruiting)
• Harbin Medical University Cancer Hospital — Harbin, China (Recruiting)
• Anhui Provincial Hospital — Hefei, China (Recruiting)
• Linyi Cancer Hospital — Linyi, China (Recruiting)
• Jiangsu Province Hospital — Nanjing, China (Recruiting)
• Jiangsu Province Hospital — Nanjing, China (Recruiting)
• Shanghai Orient Hospital — Shanghai, China (Recruiting)
• Shanghai Sixth People's Hospital — Shanghai, China (Recruiting)
• Shengjing Hospital of China Medical University — Shengjing, China (Recruiting)
• Liaoning Cancer Hospital — Shenyang, China (Recruiting)
• The First Hospital of China Medical University — Shenyang, China (Recruiting)
• The People's Hospital of Liaoning Province — Shenyang, China (Recruiting)
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, China (Recruiting)
• Shanxi Bethune Hospital — Taiyuan, China (Recruiting)
• Shanxi Provincial Cancer Hospital — Taiyuan, China (Recruiting)
• Shanxi Provincial Cancer Hospital — Taiyuan, China (Recruiting)
• Taizhou Hospital of Zhejiang Province — Taizhou, China (Recruiting)
• The Second Hospital of Tianjin Medical University — Tianjin, China (Recruiting)
• Hubei Cancer Hospital — Wuhan, China (Recruiting)
• Hubei Cancer Hospital — Wuhan, China (Recruiting)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, China (Recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China (Recruiting)
• Xi 'an International Medical Center Hospital — Xi'an, China (Recruiting)
• Xi 'an International Medical Center Hospital — Xi'an, China (Recruiting)
• Yantai Yuhuangding Hospital — Yantai, China (Recruiting)
• Yibin Second People's Hospital — Yibin, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, China (Recruiting)
• The first affilated hospital of zhengzhou university — Zhengzhou, China (Recruiting)
• The first affilated hospital of zhengzhou university — Zhengzhou, China (Recruiting)
• Zhujiang Hospital of Southern Medical University — Zhujiang, China (Recruiting)

Study contacts

• Principal investigator: Ye Guo — Shanghai Orient Hospital
• Study coordinator: Ye Guo

Conditions Malignant Neoplasm