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
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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;
Locations
Other Locations
China
Chinese PLA General Hospital
RECRUITING
Beijing
Hunan Cancer Hospital
RECRUITING
Changsha
Chongqing University Cancer Hospital
RECRUITING
Chongqing
Fujian Province Cancer Hospital
RECRUITING
Fuzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
Shandong Cancer Hospital
RECRUITING
Jinan
Jingzhou First People's Hospital
RECRUITING
Jingzhou
Yunnan Cancer Hospital (The Third Affiliated Hospital of Kunming Medical University)
RECRUITING
Kunming
Nanjing Drum Tower Hospital
RECRUITING
Nanjing
ZhongShan Hospital Fudan University
RECRUITING
Shanghai
Union Hospital Tongji Medical College of Hust
RECRUITING
Wuhan
The Central Hospital of Yongzhou
RECRUITING
Yongzhou
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Jia Song
song.j@biotheus.com
+86 15921737659
Time Frame
Start Date: 2023-05-17
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 60
Treatments
Experimental: PM8002+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.
Related Therapeutic Areas
Sponsors
Leads: Biotheus Inc.