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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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
Trial sites (13)
Facility
City
Region
Status
Chongqing University Cancer Hospital
Chongqing
Chongqing Municipality
Fujian Province Cancer Hospital
Fuzhou
Fujian
Harbin Medical University Cancer Hospital
Harbin
Heilongjiang
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Jingzhou First People's Hospital
Jingzhou
Hubei
Union Hospital Tongji Medical College of Hust
Wuhan
Hubei
Hunan Cancer Hospital
Changsha
Hunan
The Central Hospital of Yongzhou
Yongzhou
Hunan
Nanjing Drum Tower Hospital
Nanjing
Jiangsu
Shandong Cancer Hospital
Jinan
Shandong
Yunnan Cancer Hospital (The Third Affiliated Hospital of Kunming Medical University)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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