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

Last updated: December 15, 2024
Sponsor: Biotheus Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Small Cell Lung Cancer

Treatment

Paclitaxel

PM8002

Clinical Study ID

NCT05879068
PM8002-B002C-SCLC-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 paclitaxel as second line treatment for SCLC.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed informed consent form before any trial-related processes;

  2. Age ≥18 years;

  3. Histologically or cytologically confirmed SCLC;

  4. Advanced SCLC who failed first-line platinum-based chemotherapy with or withoutcheckpoint inhibitors;

  5. Have adequate organ function;

  6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;

  7. Life expectancy of ≥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. Current presence of severe superior vena cava syndrome and spinal cord compression;

  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: 99
Treatment Group(s): 2
Primary Treatment: Paclitaxel
Phase: 2
Study Start date:
May 27, 2022
Estimated Completion Date:
April 30, 2026

Study Description

This is a phase II, single arm study assessing the efficacy and safety of PM8002 in combination with paclitaxel as second line treatment for SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors therapy

Connect with a study center

  • Peking University Cancer Hospital

    Beijing,
    China

    Site Not Available

  • Jilin Provincial Tumor Hospital

    Changchun,
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha,
    China

    Site Not Available

  • Sichuan Provincial People's Hospital

    Chengdu,
    China

    Site Not Available

  • Zhejiang Provincial People's Hospital

    Hangzhou,
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin,
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan,
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang,
    China

    Site Not Available

  • Shanghai Pulmonary Hospital

    Shanghai,
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an,
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou,
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.