Actively Recruiting
A Study of PM8002 in Combination With Chemotherapy in Patients With NEN
Led by Biotheus Inc. · Updated on 2024-12-19
60
Participants Needed
13
Research Sites
241 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study of PM8002 in Combination With Chemotherapy in Patients With NEN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any trial-related procedures
- Age 18 years or older
- Histologically or cytologically confirmed Ki-6755% G3 NET or NEC
- Failure of first-line platinum-based chemotherapy
- Adequate organ function
- Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1
- Expected survival of at least 12 weeks
- At least one measurable tumor lesion according to RECIST v1.1
You will not qualify if you...
- History of severe allergic disease or known allergy to any study drug component
- History or evidence of severe bleeding tendency
- Severe cardiovascular diseases within the past 6 months
- Must provide formalin-fixed-paraffin-embedded (FFPE) tumor samples during screening (up to 24 months)
- Presence of uncontrolled pleural, pericardial, or peritoneal effusions
- History of allogeneic hematopoietic stem cell or organ transplantation
- History of alcohol, psychotropic substance, or drug abuse
- Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome
- Pregnant or lactating women
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Actively Recruiting
2
Fujian Province Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
3
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Actively Recruiting
4
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
5
Jingzhou First People's Hospital
Jingzhou, Hubei, China
Actively Recruiting
6
Union Hospital Tongji Medical College of Hust
Wuhan, Hubei, China
Actively Recruiting
7
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
8
The Central Hospital of Yongzhou
Yongzhou, Hunan, China
Actively Recruiting
9
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Actively Recruiting
10
Shandong Cancer Hospital
Jinan, Shandong, China
Actively Recruiting
11
Yunnan Cancer Hospital (The Third Affiliated Hospital of Kunming Medical University)
Kunming, Yunnan, China
Actively Recruiting
12
Chinese PLA General Hospital
Beijing, China
Actively Recruiting
13
ZhongShan Hospital Fudan University
Shanghai, China
Actively Recruiting
Research Team
J
Jia Song
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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