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

June 25, 2023 updated by: Jian Zhang,MD, Fudan University

Different Targeted Antibody-drug Conjugates for HER2 Ultra-low or no Expression Advanced Breast Cancer: a Phase Ⅰb/Ⅱ Study（GALAXY）

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Locations

  • China
      • Shanghai, China
        • Fudan University Shanghai Cancer Center

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:

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 lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.

Disease progression on at least 1 previous line of chemotherapy for recurrent/metastatic breast cancer. Subjects with HER2-negative and hormone-receptor positive tumors must have progressed 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 and willingness to sign a written informed consent document.

Exclusion Criteria:

Has previously been treated with any anti-HER2 therapy. Known prior severe hypersensitivity to investigational product or any component in its formulation and other monoclonal antibodies.

Any major surgery, radiotherapy, chemotherapy, immunotherapy or molecular targeted therapy, biotherapy or other drug clinical trial within 4 weeks; received endocrine therapy within 2 weeks before the first study drug administration.

History of other malignancy than breast cancer within 5 years prior to screening (except for cured skin basal cell carcinoma and cervical carcinoma in situ).

Meningeal metastasis or active brain parenchymal metastasis. Any concurrent use of immunosuppressant or systemic corticosteroid treatment to achieve immunosuppression purpose (dose of > 10mg/day prednisone or equivalent), and still in use within 2 weeks before the first study drug administration.

Has uncontrolled intercurrent illness or significant cardiovascular disease. History of clinically significant lung diseases. History of immunodeficiency, including HIV positive. Known active hepatitis B virus or hepatitis C virus infection. Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: HER2 ADC
Patients diagnosed with HER2 ultra-low or no expression are recruited
Drug: SHR-A1811
HER2 ADC
Experimental: Experimental: TROP2 ADC
Patients diagnosed with HER2 ultra-low or no expression are recruited.
Drug: TROP2 ADC
TROP2 ADC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of adverse events (AEs)- Phase 1
Time Frame: Up to follow-up period, approximately 24 months
Occurrence of AEs in Phase 1 graded according to CTCAE v5.0
Up to follow-up period, approximately 24 months
Objective Response Rate (ORR)- Phase 2
Time Frame: Until progression, assessed up to approximately 24 months
The proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1.
Until progression, assessed up to approximately 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS
Time Frame: Until progression, assessed up to approximately 24 months
Time to progression as assessed by the Investigator at local site per RECIST 1.1, or death due to any cause.
Until progression, assessed up to approximately 24 months
Overall Survival (OS)
Time Frame: Until death, assessed up to approximately 24 months
time to death due to any cause
Until death, assessed up to approximately 24 months
Duration of Response (DoR)
Time Frame: Until progression, assessed up to approximately 24 months
Time from the date of first documented response until the date of documented progression or death in the absence of disease progression.
Until progression, assessed up to approximately 24 months
Disease Control Rate (DCR)
Time Frame: Baseline through end of study, assessed up to 24 months
The proportion of patients who have a CR or PR or SD, as determined by the Investigator at local site per RECIST 1.1.
Baseline through end of study, assessed up to 24 months
Clinical Benefit Rate (CBR)
Time Frame: Until progression or death, assessed up to approximately 24 months
The percentage of subjects with CR, PR and SD≥24 weeks，as determined by the Investigator at local site per RECIST 1.1.
Until progression or death, assessed up to approximately 24 months
Safety
Time Frame: Up to follow-up period, approximately 24 months
Occurrence of Adverse Events(AEs) graded according to CTCAE v5.0
Up to follow-up period, approximately 24 months
Exploratory analyses
Time Frame: Baseline until disease progression or loss of clinical benefit, assessed up to 24 months
HER2-PET was done at baseline to further explore the clinical utility of HER2-PET for HER2 detection
Baseline until disease progression or loss of clinical benefit, assessed up to 24 months

Collaborators and Investigators

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

Sponsor

Fudan University

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)

March 14, 2023

Primary Completion (Estimated)

April 10, 2025

Study Completion (Estimated)

October 10, 2026

Study Registration Dates

First Submitted

March 5, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 25, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GALAXY

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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