ARX788 in HER2-positive Metastatic Breast Cancer Patients

NCT06663748 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: ACE-Breast-09
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

A phase 2 study of ARX788 given every 6 weeks in HER2-positive, metastatic breast cancer patients.

Conditions

HER2-positive, Metastatic Breast Cancer

Keywords

ARX788; HER2-positive breast cancer; Q6W

Outcome Measures

Primary Outcomes (1)

• Objective remission rate (ORR)

  ORR is defined as the percentage of participants in the analysis population who have CR or PR per RECIST 1.1.

  up to 2 years

Secondary Outcomes (15)

• Disease control rate (DCR)

  up to 2 years

• Duration of relief (DOR)

  From response initiation (when either CR or PR is first determined) to progression or death, whichever occurs first, assessed up to 2 years.

• Progression-free survival (PFS)

  From first dose to first documented disease progression (PD) or death from any cause, whichever occurred first, assessed up to 2 years.

• Overall survival (OS)

  From the date of first dose of study drug to any-cause death, assessed up to 5 years

• The number of subjects experiencing adverse event TEAEs

  up to 2 years

Study Arms (1)

ARX788

EXPERIMENTAL

Drug: ARX788

Interventions

ARX788 DRUG

2.2 mg/kg IV infusion on Day 1 of each 42-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;
• Has previously received ≤ two lines of chemotherapy (excluding hormone therapy) for recurrent or metastatic BC;
• Tissue samples determined to be HER2 positive (defined as IHC3+ or FISH+);
• Has at least one measurable target lesion as per RECIST1.1 criteria;
• Has recovered from any AE (≤ Grade 1) related to prior surgery and prior cancer treatment;
• Adequate bone marrow, liver, kidney and coagulation function;
• ECOG Performance Status Score of 0-1;
• Voluntarily sign the informed consent, have good compliance and are willing to comply with the follow-up visit.

You may not qualify if:

• Has known history to be allergic to any active ingredient or excipient of ARX788;
• With meningeal metastases or disseminated brain metastases or active brain metastases, who need radiation, surgery or drug therapy;
• Has pericardial effusion, pleural effusion or ascites effusion with clinical symptoms, signs or require symptomatic treatment;
• 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;
• Uncontrolled hypertension;
• Has evidence of severe or uncontrollable systemic diseases;
• Received live vaccines within 4 weeks before the first use of the investigational product or plans to receive live vaccines during the trial;
• Breastfeeding female, or who has childbearing potential with a positive baseline pregnancy test or who is unwilling to use effective contraception during the trial;
• Is unwilling or unable to stop wearing corneal contact lens during the trial;
• 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;
• Has any mental or cognitive disorder that may restrict his/her understanding and execution of the informed consent form;
• Other conditions that the Investigator considers inappropriate for participation in this trial, such as poor compliance.

Sponsors & Collaborators

• Henan Cancer Hospital: 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

Min Yan

CONTACT

+86 15713857388; ym200678@126.com

Study Design

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

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 29, 2024
• Study Start: November 20, 2024
• Primary Completion: November 20, 2025
• Study Completion (Estimated): November 20, 2029
• Last Updated: October 29, 2024

Record last verified: 2024-10