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

Phase 1

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Drug: SHR-A1811; Drug: TROP2 ADC

• Registration Number: NCT05824325
• Lead Sponsor: Fudan University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-05
• Study Start: 2023-03-14
• Study First Submitted QC: 2023-04-11
• Study First Posted: 2023-04-21
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-25
• Last Update Posted: 2023-06-27
• Primary Completion: 2025-04-10
• Study Completion: 2026-10-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 56

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: HER2 ADC	SHR-A1811	Patients diagnosed with HER2 ultra-low or no expression are recruited
Experimental: TROP2 ADC	TROP2 ADC	Patients diagnosed with HER2 ultra-low or no expression are recruited.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)- Phase 2	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.
Occurrence of adverse events (AEs)- Phase 1	Up to follow-up period, approximately 24 months	Occurrence of AEs in Phase 1 graded according to CTCAE v5.0

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DoR)	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.
Clinical Benefit Rate (CBR)	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.
Overall Survival (OS)	Until death, assessed up to approximately 24 months	time to death due to any cause
Progression Free Survival (PFS	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.
Safety	Up to follow-up period, approximately 24 months	Occurrence of Adverse Events(AEs) graded according to CTCAE v5.0
Disease Control Rate (DCR)	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.
Exploratory analyses	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

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China