ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd

Phase 2

Not yet recruiting

• Conditions: Breast Cancer
• Interventions: Drug: ARX788

• Registration Number: NCT06578286
• Lead Sponsor: Fudan University

Brief Summary

A single arm, phase 2 Study of ARX788 in HER2-positive metastatic breast cancer patients who were previously treated with T-DXd. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Study First Posted: 2024-08-29
• Last Update Posted: 2024-08-29
• Study Start: 2024-09-30
• Primary Completion: 2026-09-30
• Study Completion: 2030-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. 18 to 75 years old (including upper and lower limits), male or female;
2. Unresectable locally advanced, recurrent or metastatic BC;
3. Tissue samples determined to be HER2 positive (defined as IHC3+ or FISH+);
4. Received T-DXd treatment in the advanced stage;
5. Adequate bone marrow, liver, kidney and coagulation function;
6. Voluntarily sign the informed consent, have good compliance and are willing to comply with the follow-up visit.

Exclusion Criteria

1. With meningeal metastases or disseminated brain metastases or active brain metastases;
2. Has interstitial lung disease requiring steroid therapy, a history of drug-induced interstitial lung disease, a history of radiation pneumonitis, or any evidence indicating clinically active interstitial lung disease;
3. Has any eye disease that require medical intervention such as keratitis, corneal diseases or active eye infection;
4. Has cardiac insufficiency;
5. Has received any systemic anti-tumor therapy (with the exception of endocrine therapy, with an interval of at least 7 days) within 28 days (or at least 5 half-lives) before the first use of the investigational product;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARX788	ARX788	ARX788，1.5 mg/kg IV infusion on Day 1 of each 21-day treatment cycle

Primary Outcome Measures

Name	Time	Method
Objective remission rate (ORR)	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.

Secondary Outcome Measures

Name	Time	Method
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.
Duration of relief (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
Overall survival (OS)	Until death, assessed up to approximately 50 months	Time to death due to any cause
The number of subjects experiencing adverse event TEAEs	Up to follow-up period, approximately 50 months	Occurrence of AEs according to CTCAE v5.0
Progression-free survival (PFS)	Until progression or death, assessed up to approximately 36 months]	Time to progression as assessed by the Investigator at local site per RECIST 1.1, or death due to any cause.