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 groupSponsors and collaborators
Source ClinicalTrials.gov