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

• Status: Recruiting
• Trial end date: 2028-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biotheus Inc.

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.