Clinical Study of PM1003 in Phase I/IIa Treatment of Advanced Malignant Solid Tumors

Trial status:Unmapped
Trial ID:
PM1003-AB001M-ST-R
NCT ID:
NCT05862831
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
Unmapped

Trial Details

This is a single-arm, open-lable, multicenter phase I/IIa clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of PM1003 in the treatment of advanced solid tumors.

Medical Condition
Solid Tumors
Study Drug
PM1003 Injection
Phase
Phase 1/Phase 2
Type
Interventional
Estimated Enrolment
285
Estimated Trial Date
Sep 2021 - Sep 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. Subjects with malignant tumor confirmed by histology or cytology;
  4. Adequate organ function;
  5. ECOG score was 0-1.
  6. Pre-menopausal female subjects with negative blood pregnancy results within 7 days prior to the study treatment, and agree to abstain from sex or use medically approved effective contraceptive measures for 6 months from the date of signing the informed consent form to the end of the last medication;
  7. Male subjects are agree to abstain from sex or use medically approved effective contraceptive methods for 6 months from the date of signing the informed consent form to the end of the last medication, and do not donate sperm during this period.
Exclusion criteria
  1. History of severe allergic to macromolecular protein drugs, severe allergy to drugs or known allergy to any component of the drug in this study;
  2. Treatment with any 4-1BB monoclonal antibody or 4-1BB-containing dual antibody immune co-stimulatory molecule agonist;
  3. Current active infection requiring intravenous anti-infective therapy;
  4. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
  5. Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
  6. History of neurological or psychiatric disorders, such as epilepsy, dementia, schizophrenia, etc.;
  7. Anticipated need for any other form of antineoplastic drug treatment during the trial;
  8. Women who are pregnant or breastfeeding;
  9. Other conditions lead to inappropriate to participate in this study as judged by the investigator.

Trial Locations

Location
Status
Location
Cancer Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Status
Recruiting
Location
Shanghai Orient Hospital
Shanghai, China
Status
Recruiting