PM8002 in the Treatment of Patients With Advanced Solid Tumors

Trial status:Recruiting
Trial ID:
PM8002-A001
NCT ID:
NCT05918445
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Collaborator:
N/A
Recruiting

Trial Details

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.

Medical Condition
Unmapped
Study Drug
PM8002
Phase
Phase 1/Phase 2
Type
Interventional
Estimated Enrolment
380
Estimated Trial Date
Mar 2021 - Nov 2025

Trial Participant Requirements

Age
18 - 75 Years
Sex
Female & Male
Healthy Volunteers
No
Inclusion and Exclusion 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.

Trial Locations

Location
Status
Location
Baoji Central Hospital
Baoji, China
Status
Recruiting
Location
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Status
Recruiting
Location
Peking University Cancer Hospital
Beijing, China
Status
Recruiting
Location
Jilin Cancer Hospital
Changchun, China
Status
Recruiting
Location
The First Hospital of Jilin University
Changchun, China
Status
Recruiting
Location
Changde First People's Hospital
Changde, China
Status
Recruiting
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