A Study of PM8002 in Combination With Chemotherapy in Patients With NEN
A Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PM8002 Injection in Combination With Chemotherapy as Second Line Therapy in Unresectable Neuroendocrine Neoplasm
1 other identifier
interventional
60
1 country
13
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2023
Typical duration for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2023
CompletedStudy Start
First participant enrolled
May 17, 2023
CompletedFirst Posted
Study publicly available on registry
May 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
December 19, 2024
December 1, 2024
3.6 years
May 17, 2023
December 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Objective Response Rate
Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1
Up to approximately 2 years
Treatment related adverse events (TRAEs)
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
Up to 30 days after last treatment
Secondary Outcomes (4)
Disease control rate (DCR)
Up to approximately 2 years
Duration of response (DoR)
Up to approximately 2 years
Progression free survival (PFS)
Up to approximately 2 years
Overall survival (OS)
Up to approximately 2 years
Study Arms (1)
PM8002+FOLFIRI
EXPERIMENTALSubjects will be administered with PM8002 plus FOLFIRI via intravenously (IV) Q2W until disease progression or intolerable toxicity for a maximum of 2 years.
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent form before any trial-related processes;
- Aged ≥ 18 years;
- Ki-67≥55% G3 NET and NEC were confirmed histologically or cytologically by pathological diagnosis in this study;
- Subjects failed first-line platinum-based chemotherapy;
- Adequate organ function;
- The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
- Expected survival ≥ 12 weeks;
- Had at least one measurable tumor lesion according to RECIST v1.1;
You may not qualify if:
- History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
- Evidence and history of severe bleeding tendency;
- History of severe cardiovascular diseases within 6 months;
- Subjects should provide formalin-fixed-paraffin-embedded (FFPE) tumor samples during the screening period (up to 24 months);
- Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
- History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
- History of alcohol abuse, psychotropic substance abuse or drug abuse;
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
- Pregnant or lactating women;
- Other conditions considered unsuitable for this study by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biotheus Inc.lead
Study Sites (13)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianming Xu
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2023
First Posted
May 30, 2023
Study Start
May 17, 2023
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
December 19, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- After the trial completed.
- Access Criteria
- NCI is committed to sharing data in accordance with NIH policy.
The data will be published or presented for publications (poster, abstract,articles or papers) or any presentations.