A Study of PM8002 in Combination With Chemotherapy in Patients With NEN
ConditionNeuroendocrine Neoplasm
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiotheus Inc.
About this trial
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).
Eligibility criteria
Qualifiers
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;
Disqualifiers
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);
Trial design
Treatments tested in this trial
- PM8002
- FOLFIRI
Treatment groups
60 Participants
are divided into 1 treatment groupLocations
13Chongqing University Cancer Hospital ChongqingChongqing Municipality, China
Fujian Province Cancer Hospital FuzhouFujian, China
Harbin Medical University Cancer Hospital HarbinHeilongjiang, China
The First Affiliated Hospital of Zhengzhou University ZhengzhouHenan, China
Sponsors and collaborators
Biotheus Inc.
Lead sponsor
Source ClinicalTrials.gov