A Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PM8002 Injection in Combination With Chemotherapy as Second Line Therapy in Unresectable Neuroendocrine Neoplasm

Led by Biotheus Inc. · Updated on 2026-07-09

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

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).

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

Inclusion Criteria:

Signed informed consent form before any trial-related processes;
Aged ≥ 18 years;
Ki-67≥55% G3 NET and NEC were confirmed histologically or cytologically by pathological diagnosis in this study;
Subjects failed first-line platinum-based chemotherapy;
Adequate organ function;
The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
Expected survival ≥ 12 weeks;
Had at least one measurable tumor lesion according to RECIST v1.1;

Exclusion Criteria:

History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
Evidence and history of severe bleeding tendency;
History of severe cardiovascular diseases within 6 months;
Subjects should provide formalin-fixed-paraffin-embedded (FFPE) tumor samples during the screening period (up to 24 months);
Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
History of alcohol abuse, psychotropic substance abuse or drug abuse;
Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
Pregnant or lactating women;
Other conditions considered unsuitable for this study by the investigator.

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A Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PM8002 Injection in Combination With Chemotherapy as Second Line Therapy in Unresectable Neuroendocrine Neoplasm

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria