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

Study Overview
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Brief Summary
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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).

Detailed Description
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This is a phase II, single arm study assessing the efficacy and safety of PM8002 in combination with FOLFIRI as second line treatment for neuroendocrine neoplasm (NEC and Ki-67≥55% G3 NET) who failed first-line platinum-based chemotherapy

Official Title
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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

Conditions
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Neuroendocrine Neoplasm

Intervention / Treatment
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* Drug: PM8002
* Drug: FOLFIRI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PM8002+FOLFIRI<br>Subjects will be administered with PM8002 plus FOLFIRI via intravenously (IV) Q2W until disease progression or intolerable toxicity for a maximum of 2 years. | Drug: PM8002<br>* IV infusion<br>Drug: FOLFIRI<br>* IV infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1 | Up to approximately 2 years | 
| Treatment related adverse events (TRAEs) | The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0 | Up to 30 days after last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate (DCR) | DCR is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST v1.1. | Up to approximately 2 years | 
| Duration of response (DoR) | DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first | Up to approximately 2 years | 
| Progression free survival (PFS) | PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1) | Up to approximately 2 years | 
| Overall survival (OS) | OS is the time from the date of first dosing date to death due to any cause. | Up to approximately 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Second line, NEC, G3 NET