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Clinical Trials in China / NCT05879055
Active, not recruiting Phase 2

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

NCT05879055 · tracked via the Priya Life Science China tracker
Sponsor
Biotheus Inc.
Phase
Phase 2
Started
2023-05-17
Last updated
2026-07-09

Condition(s) studied

Neuroendocrine Neoplasm

Investigational drug(s) / intervention(s)

PM8002 →FOLFIRI →

PM8002: IV infusion

FOLFIRI: IV infusion

Study 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

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)

Trial sites (13)

FacilityCityRegionStatus
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) Kunming Yunnan
Chinese PLA General Hospital Beijing China
ZhongShan Hospital Fudan University Shanghai China

More Biotheus Inc. trials in China

Other trials for the same condition

Official registry record

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.

View NCT05879055 on ClinicalTrials.gov ↗ ← All trials in China