RecruitingPhase 2NCT05879055
A Study of PM8002 in Combination With Chemotherapy in Patients With NEN
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
Sponsor
Biotheus Inc.
Enrollment
60 participants
Start Date
May 17, 2023
Study Type
INTERVENTIONAL
Conditions
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).
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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 Criteria10
- 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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Interventions
DRUGPM8002
IV infusion
DRUGFOLFIRI
IV infusion
Locations(13)
View Full Details on ClinicalTrials.gov
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NCT05879055
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