A Study of PM8002 in Combination With Chemotherapy in Patients With NEN
NCT ID: NCT05879055
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2023-05-17
2028-01-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
PM8002
IV infusion
FOLFIRI
IV infusion
Interventions
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PM8002
IV infusion
FOLFIRI
IV infusion
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Biotheus Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jianming Xu
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
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Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 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
Chinese PLA General Hospital
Beijing, , China
ZhongShan Hospital Fudan University
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Yan Li
Role: primary
Jianwei Yang
Role: primary
Yuxian Bai
Role: primary
Lijie Song
Role: primary
Jun Cai
Role: primary
Hongli Liu
Role: primary
Zhenyang Liu
Role: primary
Pengfei Luo
Role: primary
Baorui Liu
Role: primary
Qin Liu
Role: backup
Zuoxing Niu
Role: primary
Lin Xie
Role: primary
Jianming Xu
Role: primary
Tianshu Liu
Role: primary
Other Identifiers
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PM8002-B009C-NEN-R
Identifier Type: -
Identifier Source: org_study_id