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

Last updated: December 17, 2024
Sponsor: Biotheus Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Digestive System Neoplasms

Abdominal Cancer

Carcinoid Syndrome And Carcinoid Tumours

Treatment

FOLFIRI

PM8002

Clinical Study ID

NCT05879055
PM8002-B009C-NEN-R
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 bypathological 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

Exclusion Criteria:

  1. History of severe allergic disease, severe drug allergy or have known allergy to anycomponent 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 duringthe 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 organtransplantation;

  7. History of alcohol abuse, psychotropic substance abuse or drug abuse;

  8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiencysyndrome;

  9. Pregnant or lactating women;

  10. Other conditions considered unsuitable for this study by the investigator.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: FOLFIRI
Phase: 2
Study Start date:
May 17, 2023
Estimated Completion Date:
January 01, 2028

Study 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

Connect with a study center

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing
    China

    Active - Recruiting

  • Fujian Province Cancer Hospital

    Fuzhou, Fujian
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Active - Recruiting

  • Jingzhou First People's Hospital

    Jingzhou, Hubei
    China

    Active - Recruiting

  • Union Hospital Tongji Medical College of Hust

    Wuhan, Hubei
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan
    China

    Active - Recruiting

  • The Central Hospital of Yongzhou

    Yongzhou, Hunan
    China

    Active - Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu
    China

    Active - Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong
    China

    Active - Recruiting

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

    Kunming, Yunnan
    China

    Active - Recruiting

  • Chinese PLA General Hospital

    Beijing,
    China

    Active - Recruiting

  • ZhongShan Hospital Fudan University

    Shanghai,
    China

    Active - Recruiting

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