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Trial Title:
A Study of PM8002 Injection in Combination With Chemotherapy in Patients With NEN
NCT ID:
NCT05879055
Condition:
Neuroendocrine Neoplasm
Conditions: Official terms:
Neoplasms
Neuroendocrine Tumors
Conditions: Keywords:
Second line
NEC
G3 NET
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PM8002
Description:
IV infusion
Arm group label:
PM8002+FOLFIRI
Intervention type:
Drug
Intervention name:
FOLFIRI
Description:
IV infusion
Arm group label:
PM8002+FOLFIRI
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).
Detailed description:
This is a phase II, single arm study assessing the efficacy and safety of PM8002 in
combination with FOLFIRI as second line treatment for neuroendocrine neoplasm (NEC and
Ki-67≥55% G3 NET) who failed first-line platinum-based chemotherapy
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chinese PLA General Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianming Xu
Email:
Jianmingxu2014@163.com
Investigator:
Last name:
Jianming Xu
Email:
Principal Investigator
Start date:
May 17, 2023
Completion date:
January 1, 2028
Lead sponsor:
Agency:
Biotheus Inc.
Agency class:
Industry
Source:
Biotheus Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05879055
