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

December 17, 2024 updated by: Biotheus Inc.

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Chinese PLA General Hospital
        • Principal Investigator:
          • Jianming Xu
        • Contact:
      • Shanghai, China
        • Recruiting
        • Zhongshan Hospital Fudan University
        • Principal Investigator:
          • Tianshu Liu
        • Contact:
          • Tianshu Liu
    • Chongqing
      • Chongqing, Chongqing, China
        • Recruiting
        • Chongqing University Cancer Hospital
        • Principal Investigator:
          • Yan Li
        • Contact:
          • Yan Li
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Province Cancer Hospital
        • Contact:
          • Jianwei Yang
        • Principal Investigator:
          • Jianwei Yang
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • Harbin medical university cancer hospital
        • Principal Investigator:
          • Yuxian Bai
        • Contact:
          • Yuxian Bai
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • The first affiliated hospital of Zhengzhou university
        • Contact:
          • Lijie Song
        • Principal Investigator:
          • Lijie Song
    • Hubei
      • Jingzhou, Hubei, China
        • Recruiting
        • Jingzhou First People's Hospital
        • Contact:
          • Jun Cai
        • Principal Investigator:
          • Jun Cai
      • Wuhan, Hubei, China
        • Recruiting
        • Union Hospital Tongji Medical College of HUST
        • Contact:
          • Hongli Liu
        • Principal Investigator:
          • Hongli Liu
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Zhenyang Liu
        • Principal Investigator:
          • Zhenyang Liu
      • Yongzhou, Hunan, China
        • Recruiting
        • The Central Hospital of Yongzhou
        • Principal Investigator:
          • Pengfei Luo
        • Contact:
          • Pengfei Luo
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
          • Qin Liu
        • Principal Investigator:
          • Baorui Liu
        • Contact:
          • Baorui Liu
        • Principal Investigator:
          • Qin Liu
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Cancer Hospital
        • Contact:
          • Zuoxing Niu
        • Principal Investigator:
          • Zuoxing Niu
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • Yunnan Cancer Hospital (The Third Affiliated Hospital of Kunming Medical University)
        • Principal Investigator:
          • Lin Xie
        • Contact:
          • Lin Xie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PM8002+FOLFIRI
Subjects will be administered with PM8002 plus FOLFIRI via intravenously (IV) Q2W until disease progression or intolerable toxicity for a maximum of 2 years.
Drug: FOLFIRI
IV infusion
Drug: PM8002
IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment related adverse events (TRAEs)
Time Frame: Up to 30 days after last treatment
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
Up to 30 days after last treatment
Objective Response Rate
Time Frame: Up 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
Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate (DCR)
Time Frame: 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.
Up to approximately 2 years
Overall survival (OS)
Time Frame: Up to approximately 2 years
OS is the time from the date of first dosing date to death due to any cause.
Up to approximately 2 years
Duration of response (DoR)
Time Frame: 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
Up to approximately 2 years
Progression free survival (PFS)
Time Frame: 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)
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotheus Inc.

Investigators

  • Principal Investigator: Jianming Xu, Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2023

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

May 17, 2023

First Submitted That Met QC Criteria

May 25, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM8002-B009C-NEN-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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