Back to resultsA Study of PM8002 Injection in Combination With Chemotherapy in Patients With NEN
Primary Purpose
Neuroendocrine Neoplasm
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
PM8002
FOLFIRI
Sponsored by
About this trial
This is an interventional treatment trial for Neuroendocrine Neoplasm focused on measuring Second line, NEC, G3 NET
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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.
Sites / Locations
- Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PM8002+FOLFIRI
Arm Description
Subjects will be administered with PM8002 plus FOLFIRI via intravenously (IV) Q2W until disease progression or intolerable toxicity for a maximum of 2 years.
Outcomes
Primary Outcome Measures
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
Treatment related adverse events (TRAEs)
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
Secondary Outcome Measures
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST v1.1.
Duration of response (DoR)
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first
Progression free survival (PFS)
PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1)
Overall survival (OS)
OS is the time from the date of first dosing date to death due to any cause.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05879055
Brief Title
A Study of PM8002 Injection in Combination With Chemotherapy in Patients With NEN
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2023 (Actual)
Primary Completion Date
January 1, 2027 (Anticipated)
Study Completion Date
January 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotheus Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Neoplasm
Keywords
Second line, NEC, G3 NET
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PM8002+FOLFIRI
Arm Type
Experimental
Arm Description
Subjects will be administered with PM8002 plus FOLFIRI via intravenously (IV) Q2W until disease progression or intolerable toxicity for a maximum of 2 years.
Intervention Type
Drug
Intervention Name(s)
PM8002
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
FOLFIRI
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1
Time Frame
Up to approximately 2 years
Title
Treatment related adverse events (TRAEs)
Description
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
Time Frame
Up to 30 days after last treatment
Secondary Outcome Measure Information:
Title
Disease control rate (DCR)
Description
DCR is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST v1.1.
Time Frame
Up to approximately 2 years
Title
Duration of response (DoR)
Description
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first
Time Frame
Up to approximately 2 years
Title
Progression free survival (PFS)
Description
PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1)
Time Frame
Up to approximately 2 years
Title
Overall survival (OS)
Description
OS is the time from the date of first dosing date to death due to any cause.
Time Frame
Up to approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Song
Phone
+86 15921737659
Email
song.j@biotheus.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianming Xu
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianming Xu
Email
Jianmingxu2014@163.com
First Name & Middle Initial & Last Name & Degree
Jianming Xu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be published or presented for publications (poster, abstract,articles or papers) or any presentations.
IPD Sharing Time Frame
After the trial completed.
IPD Sharing Access Criteria
NCI is committed to sharing data in accordance with NIH policy.
Learn more about this trial
A Study of PM8002 Injection in Combination With Chemotherapy in Patients With NEN
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