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

Neuroendocrine Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05879055
• Other study ID #: PM8002-B009C-NEN-R
• Status: Recruiting
• Phase: Phase 2
• Start date: May 17, 2023
• Est. completion date: January 1, 2028

Study information

• Verified date: May 2023
• Source: Biotheus Inc.
• Contact: Jia Song
• Phone: +86 15921737659
• Email: song.j[@]biotheus.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Neuroendocrine Neoplasm
• Neuroendocrine Tumors

Intervention

Drug:
• PM8002
IV infusion
• FOLFIRI
IV infusion

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Biotheus Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Disease control rate (DCR)	DCR is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST v1.1.	Up to approximately 2 years
Secondary	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	Up to approximately 2 years
Secondary	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)	Up to approximately 2 years
Secondary	Overall survival (OS)	OS is the time from the date of first dosing date to death due to any cause.	Up to approximately 2 years