A Study to Evaluate of PM8002 Combined With PM1009 in Patients With First‑line HCC

Trial status:Will Be Recruiting
Trial ID:
PM80021009-AB001C-HCC-R
NCT ID:
NCT06584071
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
Will Be Recruiting

Trial Details

This study to evaluate the preliminary efficacy, safety and pharmacokinetics of PM8002 combined with PM1009 in Patients with first-line Hepatocellular Carcinoma.

Medical Condition
Unmapped
Study Drug
PM8002
See more
PM1009
atezolizumab
bevacizumab
Phase
Phase 1/Phase 2
Type
Interventional
Estimated Enrolment
140
Estimated Trial Date
Dec 2024 - Oct 2026

Trial Participant Requirements

Age
18+ years
Sex
Female & Male
Healthy Volunteers
No
Inclusion and Exclusion Criteria
Inclusion criteria
  1. Voluntary participation in clinical studies;
  2. Male or female, aged ≥ 18 years;
  3. Pathologically or clinically confirmed (according to AASLD), unresectable locally advanced and/or metastatic HCC;
  4. Child-Pugh liver function score ≤7；
  5. No prior systemic therapy for locally advanced or metastatic and/or unresectable HCC；
  6. At least 1 measurable lesion ；
  7. Adequate organ function；
  8. ECOG score of 0 to 1；
  9. Life expectancy ≥ 12 weeks;
Exclusion criteria
  1. Pathologically confirmed fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma and other components；
  2. History of serious allergic diseases；
  3. The toxicity of previous anti-tumor therapy has not been alleviated；
  4. History of severe cardiovascular diseases within 6 months;
  5. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
  6. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
  7. History of alcohol abuse, psychotropic substance abuse or drug abuse;
  8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
  9. Pregnant or lactating women;
  10. Other conditions considered unsuitable for this study by the investigator.

Trial Locations

No locations found.