A Study of PM8002 in Combination With Chemotherapy in Patients With NEN

Trial status:Recruitment Complete
Trial ID:
PM8002-B009C-NEN-R
NCT ID:
NCT05879055
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
Recruitment Complete

Trial Details

PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with FOLFIRI as second line treatment for neuroendocrine neoplasm (NEC and Ki-67≥55% G3 NET).

Medical Condition
Unmapped
Study Drug
PM8002
See more
FOLFIRI
Phase
Phase 2
Type
Interventional
Estimated Enrolment
31
Estimated Trial Date
May 2023 - Jan 2027

Trial Participant Requirements

Age
18+ years
Sex
Female & Male
Healthy Volunteers
No
Inclusion and Exclusion Criteria
Inclusion criteria
  1. Signed informed consent form before any trial-related processes;
  2. Aged ≥ 18 years;
  3. Ki-67≥55% G3 NET and NEC were confirmed histologically or cytologically by pathological diagnosis in this study;
  4. Subjects failed first-line platinum-based chemotherapy;
  5. Adequate organ function;
  6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
  7. Expected survival ≥ 12 weeks;
  8. Had at least one measurable tumor lesion according to RECIST v1.1;
Exclusion criteria
  1. History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
  2. Evidence and history of severe bleeding tendency;
  3. History of severe cardiovascular diseases within 6 months;
  4. Subjects should provide formalin-fixed-paraffin-embedded (FFPE) tumor samples during the screening period (up to 24 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

Location
Status
Location
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Status
Location
Fujian Province Cancer Hospital
Fuzhou, Fujian, China
Status
Location
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Status
Location
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Status
Location
Jingzhou First People's Hospital
Jingzhou, Hubei, China
Status
Location
Union Hospital Tongji Medical College of Hust
Wuhan, Hubei, China
Status
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