ARX788 in Breast Cancer With Low Expression of HER2

NCT05018676 | Unknown Phase 2

• 1 other identifier: ACE-Breast-07
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 2 Study of ARX788 in unresectable and/or metastatic breast cancer with low expression of HER2.

Conditions

Breast Cancer With Low Expression of HER2

Keywords

ARX788; Breast cancer; Low expression of HER2

Outcome Measures

Primary Outcomes (1)

• Objective remission rate (ORR)

  ORR is defined as the percentage of subjects who have achieved complete response and partial response according RECIST 1.1

  2 years

Secondary Outcomes (4)

• Progression-free survival (PFS)

  2 years

• Overall survival (OS)

  2 years

• Disease control rate (DCR)

  2 years

• Duration of relief (DOR)

  2 years

Study Arms (1)

ARX788

EXPERIMENTAL

Drug: ARX788

Interventions

ARX788 DRUG

1.5 mgkg 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:

• Willing and able to understand and sign an informed consent inform;
• Age ≥18 years, and ≤75 years, male or female;
• Diagnosed as HR arbitrary/HER2 low expression unresectable and/or metastatic breast cancer. HER2 low expression is defined as HER2 IHC 1+ (FISH negative or FISH not done) or HER2 IHC 2+ and FISH negative;
• Received ≥2 lines of systemic chemotherapy regimens for recurrent or metastatic disease, and for HR positive subjects, also need to have received ≥2-line endocrine therapy ± targeted therapy (including neoadjuvant/adjuvant therapy);
• Never had a HER2 positive result (IHC 3+ or FISH+) in previous pathological examinations;
• Have archived or fresh tumor tissue samples for HER2 status confirmation;
• According to the RECIST 1.1 standard, there is at least one measurable lesion;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or1; LVEF≥50%;
• Adequate organ functions;
• Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade ≤1;
• Life expectancy ≥ 3 months.

You may not qualify if:

• History of allergic reactions to any component of ARX788, or with a history of protein drug allergy, a history of specific allergies (asthma, rheumatism, eczematous dermatitis), or a history of other severe allergic reactions, who are unsuitable for ARX788 treatment as per the investigator's judgments;
• Previous treatment with T-DM1 or other HER2-ADC drugs;
• Have other malignant tumors within 5 years before signing the informed consent form (except for non-melanoma skin cancer, cervical carcinoma in situ or other tumors that have been effectively treated, except malignant tumors that are considered cured);
• Have primary central nervous system (CNS) tumors or CNS metastases;
• Prior history of interstitial pulmonary disease requiring hormone therapy, drug-induced interstitial pulmonary disease, radiation pneumonia, or current clinically active interstitial pulmonary disease;
• Suffering from keratitis, corneal diseases, retinal diseases or active eye infections that require intervention;
• Unwilling or unable to stop wearing contact lenses for the duration of the study;
• Cardiac insufficiency;
• Uncontrolled hypertension;
• Suffering severe or uncontrolled systemic diseases;
• Had chemotherapy, radiotherapy, or immunotherapy within 4 weeks before the first dose;
• Had breast cancer endocrine therapy within 2 weeks before the first dose;
• Had palliative radiotherapy for bone metastasis within 2 weeks before the first dose;
• Any uncontrolled infection, or other conditions that may limit trial compliance or interfere with evaluation;
• Current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus or syphilis;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

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

Ting Li

CONTACT

+8618121299346; cinderellaliting@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: Professor

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: August 24, 2021
• Study Start: October 20, 2021
• Primary Completion: December 30, 2022
• Study Completion: June 30, 2023
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)