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

Primary Purpose

Breast Cancer

Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR-A1811
TROP2 ADC
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: ECOG Performance Status of 0 or 1 Pathologically documented breast cancer that: is advanced or metastatic is histologically confirmed to be HER2 IHC 0 (ISH- or untested) 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.

Sites / Locations

  • Fudan University Shanghai Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Experimental: HER2 ADC

Experimental: TROP2 ADC

Arm Description

Patients diagnosed with HER2 ultra-low or no expression are recruited

Patients diagnosed with HER2 ultra-low or no expression are recruited.

Outcomes

Primary Outcome Measures

Occurrence of adverse events (AEs)- Phase 1
Occurrence of AEs in Phase 1 graded according to CTCAE v5.0
Objective Response Rate (ORR)- Phase 2
The proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1.

Secondary Outcome Measures

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

Full Information

First Posted
March 5, 2023
Last Updated
June 25, 2023
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05824325
Brief Title
Different Targeted Antibody-drug Conjugates For HER2 Ultra-low or No Expression Advanced Breast Cancer(GALAXY)
Official Title
Different Targeted Antibody-drug Conjugates for HER2 Ultra-low or no Expression Advanced Breast Cancer: a Phase Ⅰb/Ⅱ Study(GALAXY)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 14, 2023 (Actual)
Primary Completion Date
April 10, 2025 (Anticipated)
Study Completion Date
October 10, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: HER2 ADC
Arm Type
Experimental
Arm Description
Patients diagnosed with HER2 ultra-low or no expression are recruited
Arm Title
Experimental: TROP2 ADC
Arm Type
Experimental
Arm Description
Patients diagnosed with HER2 ultra-low or no expression are recruited.
Intervention Type
Drug
Intervention Name(s)
SHR-A1811
Intervention Description
HER2 ADC
Intervention Type
Drug
Intervention Name(s)
TROP2 ADC
Intervention Description
TROP2 ADC
Primary Outcome Measure Information:
Title
Occurrence of adverse events (AEs)- Phase 1
Description
Occurrence of AEs in Phase 1 graded according to CTCAE v5.0
Time Frame
Up to follow-up period, approximately 24 months
Title
Objective Response Rate (ORR)- Phase 2
Description
The proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1.
Time Frame
Until progression, assessed up to approximately 24 months
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS
Description
Time to progression as assessed by the Investigator at local site per RECIST 1.1, or death due to any cause.
Time Frame
Until progression, assessed up to approximately 24 months
Title
Overall Survival (OS)
Description
time to death due to any cause
Time Frame
Until death, assessed up to approximately 24 months
Title
Duration of Response (DoR)
Description
Time from the date of first documented response until the date of documented progression or death in the absence of disease progression.
Time Frame
Until progression, assessed up to approximately 24 months
Title
Disease Control Rate (DCR)
Description
The proportion of patients who have a CR or PR or SD, as determined by the Investigator at local site per RECIST 1.1.
Time Frame
Baseline through end of study, assessed up to 24 months
Title
Clinical Benefit Rate (CBR)
Description
The percentage of subjects with CR, PR and SD≥24 weeks,as determined by the Investigator at local site per RECIST 1.1.
Time Frame
Until progression or death, assessed up to approximately 24 months
Title
Exploratory analyses
Description
HER2-PET was done at baseline to further explore the clinical utility of HER2-PET for HER2 detection
Time Frame
Baseline until disease progression or loss of clinical benefit, assessed up to 24 months
Title
Safety
Description
Occurrence of Adverse Events(AEs) graded according to CTCAE v5.0
Time Frame
Up to follow-up period, approximately 24 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ECOG Performance Status of 0 or 1 Pathologically documented breast cancer that: is advanced or metastatic is histologically confirmed to be HER2 IHC 0 (ISH- or untested) 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.
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
Country
China

12. IPD Sharing Statement

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

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