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

Evaluate the Efficacy and Safety of ARX788 in Patients With HER2-positive Advanced Breast Cancer Whose Disease Has Progressed Following T-DXd Therapy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: ARX788

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jian Zhang, MD,PhD; Phone Number: 85000 +8664175590; Email: syner2000@163.com
• Study Contact Backup: Name: Yanchun Meng, MD; Phone Number: 85000 +8664175590; Email: ycmnankai@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARX788; ARX788，1.5 mg/kg IV infusion on Day 1 of each 21-day treatment cycle	Drug: ARX788; ARX788，1.5 mg/kg IV infusion on Day 1 of each 21-day treatment cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective remission rate (ORR)	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
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.	Baseline through end of study, assessed up to 24 months]
Duration of relief (DOR)	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
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.	Until progression or death, assessed up to approximately 36 months]
Overall survival (OS)	Time to death due to any cause	Until death, assessed up to approximately 50 months
The number of subjects experiencing adverse event TEAEs	Occurrence of AEs according to CTCAE v5.0	Up to follow-up period, approximately 50 months

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2030

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ACE-Breast-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No