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

NCT06578286 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: ACE-Breast-10
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Disease control rate (DCR)

  Baseline through end of study, assessed up to 24 months]

• Duration of relief (DOR)

  Until progression, assessed up to approximately 24 months

• Progression-free survival (PFS)

  Until progression or death, assessed up to approximately 36 months]

• Overall survival (OS)

  Until death, assessed up to approximately 50 months

• The number of subjects experiencing adverse event TEAEs

  Up to follow-up period, approximately 50 months

Study Arms (1)

ARX788

EXPERIMENTAL

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

Drug: ARX788

Interventions

ARX788 DRUG

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

ARX788

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• With meningeal metastases or disseminated brain metastases or active brain metastases;
• 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;
• Has any eye disease that require medical intervention such as keratitis, corneal diseases or active eye infection;
• Has cardiac insufficiency;
• 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;

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ARX788

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jian Zhang, MD,PhD

CONTACT

+8664175590; syner2000@163.com

Yanchun Meng, MD

CONTACT

+8664175590; ycmnankai@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2030
• Last Updated: August 29, 2024

Record last verified: 2024-08