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

Trial status:Recruitment Complete
Trial ID:
PM8002-B002C-SCLC-R
NCT ID:
NCT05879068
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 paclitaxel as second line treatment for SCLC.

Medical Condition
Unmapped
Study Drug
PM8002
See more
Paclitaxel
Phase
Phase 2
Type
Interventional
Estimated Enrolment
99
Estimated Trial Date
May 2022 - Apr 2025

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. Age ≥18 years;
  3. Histologically or cytologically confirmed SCLC;
  4. Advanced SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors;
  5. Have adequate organ function;
  6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
  7. Life expectancy of ≥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. Current presence of severe superior vena cava syndrome and spinal cord compression;
  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
Peking University Cancer Hospital
Beijing, China
Status
Location
Jilin Provincial Tumor Hospital
Changchun, China
Status
Location
Hunan Cancer Hospital
Changsha, China
Status
Location
Sichuan Provincial People's Hospital
Chengdu, China
Status
Location
Zhejiang Provincial People's Hospital
Hangzhou, China
Status
Location
Harbin Medical University Cancer Hospital
Harbin, China
Status
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