Different Targeted Antibody-drug Conjugates For HER2 Ultra-low or No Expression Advanced Breast Cancer(GALAXY)

Last updated: June 25, 2023
Sponsor: Fudan University
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Breast Cancer

Cancer

Treatment

SHR-A1811

TROP2 ADC

Clinical Study ID

NCT05824325
GALAXY
  • Ages 18-75
  • Female

Study Summary

This is a phaseⅠb/Ⅱ, open-label, two-arm parallel study evaluating the efficacy and safety of different targeted antibody-drug conjugates for HER2 ultra-low or no expression advanced breast cancer

Eligibility Criteria

Inclusion

Inclusion Criteria: ECOG Performance Status of 0 or 1 Pathologically documented breast cancer that:

  1. is advanced or metastatic
  2. is histologically confirmed to be HER2 IHC 0 (ISH- or untested)
  3. was never previously HER2-positive (IHC 3+ or ISH+) At least one measurable lesionaccording to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1. Disease progression on at least 1 previous line of chemotherapy for recurrent/metastaticbreast cancer. Subjects with HER2-negative and hormone-receptor positive tumors must haveprogressed after at least 1 line of endocrine therapy with or without CDK4/6 inhibitor. Has protocol-defined adequate organ and bone marrow function. Ability to understand andwillingness to sign a written informed consent document.

Exclusion

Exclusion Criteria: Has previously been treated with any anti-HER2 therapy. Known prior severe hypersensitivityto investigational product or any component in its formulation and other monoclonalantibodies. Any major surgery, radiotherapy, chemotherapy, immunotherapy or molecular targeted therapy,biotherapy or other drug clinical trial within 4 weeks; received endocrine therapy within 2weeks before the first study drug administration. History of other malignancy than breast cancer within 5 years prior to screening (exceptfor cured skin basal cell carcinoma and cervical carcinoma in situ). Meningeal metastasis or active brain parenchymal metastasis. Any concurrent use ofimmunosuppressant or systemic corticosteroid treatment to achieve immunosuppression purpose (dose of > 10mg/day prednisone or equivalent), and still in use within 2 weeks before thefirst study drug administration. Has uncontrolled intercurrent illness or significant cardiovascular disease. History ofclinically significant lung diseases. History of immunodeficiency, including HIV positive.Known active hepatitis B virus or hepatitis C virus infection. Has any medical history orcondition that per protocol or in the opinion of the investigator is inappropriate for thestudy.

Study Design

Total Participants: 56
Treatment Group(s): 2
Primary Treatment: SHR-A1811
Phase: 1/2
Study Start date:
March 14, 2023
Estimated Completion Date:
October 10, 2026

Connect with a study center

  • Fudan University Shanghai Cancer Center

    Shanghai,
    China

    Site Not Available

Map preview placeholder

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.