Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05879055

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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