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

Phase 2

Recruiting

• Conditions: Neuroendocrine Neoplasm
• Interventions: Drug: PM8002; Drug: FOLFIRI

• Registration Number: NCT05879055
• Lead Sponsor: Biotheus Inc.

Brief 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).

Detailed Description

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

Study Timeline

• Study Start: 2023-05-17
• Study First Submitted: 2023-05-17
• Study First Submitted QC: 2023-05-25
• Study First Posted: 2023-05-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-19
• Primary Completion: 2027-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PM8002+FOLFIRI	PM8002	Subjects will be administered with PM8002 plus FOLFIRI via intravenously (IV) Q2W until disease progression or intolerable toxicity for a maximum of 2 years.
PM8002+FOLFIRI	FOLFIRI	Subjects will be administered with PM8002 plus FOLFIRI via intravenously (IV) Q2W until disease progression or intolerable toxicity for a maximum of 2 years.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	Up to approximately 2 years	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)
Overall survival (OS)	Up to approximately 2 years	OS is the time from the date of first dosing date to death due to any cause.
Duration of response (DoR)	Up to approximately 2 years	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
Disease control rate (DCR)	Up to approximately 2 years	DCR is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST v1.1.

Trial Locations

Locations (13)

Chongqing University Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China

Fujian Province Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, Heilongjiang, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Jingzhou First People's Hospital; 🇨🇳 Jingzhou, Hubei, China

Union Hospital Tongji Medical College of Hust; 🇨🇳 Wuhan, Hubei, China

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China

The Central Hospital of Yongzhou; 🇨🇳 Yongzhou, Hunan, China

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China

Shandong Cancer Hospital; 🇨🇳 Jinan, Shandong, China

Yunnan Cancer Hospital (The Third Affiliated Hospital of Kunming Medical University); 🇨🇳 Kunming, Yunnan, China

ZhongShan Hospital Fudan University; 🇨🇳 Shanghai, China

Chinese PLA General Hospital; 🇨🇳 Beijing, China