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

NCT ID: NCT06578286

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2030-09-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARX788

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

Group Type: EXPERIMENTAL

ARX788

Intervention Type: DRUG

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

Interventions

ARX788

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

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Jian Zhang,MD

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jian Zhang, MD,PhD

Role: CONTACT

syner2000@163.com

+8664175590 ext. 85000

Yanchun Meng, MD

Role: CONTACT

ycmnankai@126.com

+8664175590 ext. 85000

Other Identifiers

ACE-Breast-10

Identifier Type: -

Identifier Source: org_study_id