PM8002 in the Treatment of Patients With Advanced Solid Tumors

Last updated: December 3, 2024
Sponsor: Biotheus Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

PM8002

Clinical Study ID

NCT05918445
PM8002-A001
  • Ages 18-75
  • All Genders

Study 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

Inclusion Criteria:

  1. Voluntary participation in clinical study; fully understand the study and signinformed consent voluntarily; willing to follow and able to complete all testprocedures;

  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 beenpreviously treated locally.

Exclusion

Exclusion Criteria:

  1. History of severe allergic disease, severe allergy to drugs or known allergy to anycomponent 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-infectiouspneumonia, unless it is caused by local radiotherapy;

  4. Patients with uncontrolled brain metastases should be excluded from this clinicaltrial;

  5. Patients ever experienced other active malignant tumors within 5 years prior to thestudy treatment;

  6. Prior allogeneic organ transplantation or allogeneic hematopoietic stem celltransplantation;

  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 theinvestigator.

Study Design

Total Participants: 380
Treatment Group(s): 1
Primary Treatment: PM8002
Phase: 1/2
Study Start date:
March 09, 2021
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Baoji Central Hospital

    Baoji,
    China

    Active - Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing,
    China

    Active - Recruiting

  • Peking University Cancer Hospital

    Beijing,
    China

    Active - Recruiting

  • Jilin Cancer Hospital

    Changchun,
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    Changchun,
    China

    Active - Recruiting

  • Changde First People's Hospital

    Changde,
    China

    Active - Recruiting

  • Hunan Provincial People's Hospital

    Changsha,
    China

    Active - Recruiting

  • The First People's Hospital of Changzhou

    Changzhou,
    China

    Active - Recruiting

  • Chengdu Integrated TCM& Western Medicine Hospital

    Chengdu,
    China

    Active - Recruiting

  • Sichuan Cancer Hospital

    Chengdu,
    China

    Active - Recruiting

  • Chongqing Cancer Hospital

    Chongqing,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing,
    China

    Active - Recruiting

  • The Southwest Hospital of AMU

    Chongqing,
    China

    Active - Recruiting

  • Fujian Cancer Hospital

    Fuzhou,
    China

    Active - Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou,
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin,
    China

    Active - Recruiting

  • Anhui Provincial Hospital

    Hefei,
    China

    Active - Recruiting

  • Linyi Cancer Hospital

    Linyi,
    China

    Active - Recruiting

  • Jiangsu Province Hospital

    Nanjing,
    China

    Active - Recruiting

  • Shanghai Orient Hospital

    Shanghai,
    China

    Active - Recruiting

  • Shanghai Sixth People's Hospital

    Shanghai,
    China

    Active - Recruiting

  • Shengjing Hospital of China Medical University

    Shengjing,
    China

    Active - Recruiting

  • Liaoning Cancer Hospital

    Shenyang,
    China

    Active - Recruiting

  • The First Hospital of China Medical University

    Shenyang,
    China

    Active - Recruiting

  • The People's Hospital of Liaoning Province

    Shenyang,
    China

    Active - Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang,
    China

    Active - Recruiting

  • Shanxi Bethune Hospital

    Taiyuan,
    China

    Active - Recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan,
    China

    Active - Recruiting

  • Taizhou Hospital of Zhejiang Province

    Taizhou,
    China

    Active - Recruiting

  • The Second Hospital of Tianjin Medical University

    Tianjin,
    China

    Active - Recruiting

  • Hubei Cancer Hospital

    Wuhan,
    China

    Active - Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an,
    China

    Active - Recruiting

  • Xi 'an International Medical Center Hospital

    Xi'an,
    China

    Active - Recruiting

  • Yantai Yuhuangding Hospital

    Yantai,
    China

    Active - Recruiting

  • Yibin Second People's Hospital

    Yibin,
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou,
    China

    Active - Recruiting

  • The first affilated hospital of zhengzhou university

    Zhengzhou,
    China

    Active - Recruiting

  • Zhujiang Hospital of Southern Medical University

    Zhujiang,
    China

    Active - Recruiting

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