Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT05879055

Recruiting

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

Interventional

Phase 2

Chinese PLA General Hospital

Sponsor: Biotheus

Last Updated: December 19, 2024
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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).

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Treatment Category

Other Drugs, Chemotherapy

Required Mutations

None

Trial Started

May 17, 2023

Last Updated by Sponsor

December 19, 2024

Estimated Completion

January 1, 2027

Contact Study

Name:Jia Song

Email:song.j@biotheus.com

Phone:+86 15921737659

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.

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Design Details

AllocationN/A

Intervention ModelSingle Group Assignment

MaskingNone (Open Label)

Number to Enroll60

Arms & Interventions

Arms

Interventions

Type: Experimental

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.

Interventions:

PM8002
FOLFIRI

Outcome Measures

Primary Outcome Measures

Objective Response RateUp to approximately 2 years

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)Up to 30 days after last treatment

The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0

Secondary Outcome Measures

Disease control rate (DCR)Up to approximately 2 years

DCR is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST v1.1.

Duration of response (DoR)Up to approximately 2 years

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)Up to approximately 2 years

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)Up to approximately 2 years

OS is the time from the date of first dosing date to death due to any cause.

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Trial Sites

This study has 13 trial sites

Chinese PLA General Hospital

Beijing, CN

Name:Jianming Xu

Email:Jianmingxu2014@163.com

Recruiting

Beijing, CN

Chinese PLA General Hospital

Recruiting

Harbin, Heilongjiang, CN

Harbin Medical University Cancer Hospital

Recruiting

Changsha, Hunan, CN

Hunan Cancer Hospital

Recruiting

Zhengzhou, Henan, CN

The First Affiliated Hospital of Zhengzhou University

Recruiting

Jinan, Shandong, CN

Shandong Cancer Hospital

Recruiting

Nanjing, Jiangsu, CN

Nanjing Drum Tower Hospital

Recruiting

Shanghai, CN

ZhongShan Hospital Fudan University

Recruiting

Yongzhou, Hunan, CN

The Central Hospital of Yongzhou

Recruiting

Wuhan, Hubei, CN

Union Hospital Tongji Medical College of Hust

Recruiting

Kunming, Yunnan, CN

Yunnan Cancer Hospital (The Third Affiliated Hospital of Kunming Medical University)

Recruiting

Fuzhou, Fujian, CN

Fujian Province Cancer Hospital

Recruiting

Jingzhou, Hubei, CN

Jingzhou First People's Hospital

Recruiting

Chongqing, Chongqing Municipality, CN

Chongqing University Cancer Hospital

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