ARX788 in Breast Cancer With Low Expression of HER2

Phase 2

• Conditions: Breast Cancer With Low Expression of HER2
• Interventions: Drug: ARX788

• Registration Number: NCT05018676
• Lead Sponsor: Fudan University

Brief Summary

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

Detailed Description

A single arm, phase 2 study of ARX788 in unresectable and/or metastatic breast cancer with low expression of HER2. Subjects should 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). HER2 low expression is defined as HER2 IHC 1+ or HER2 IHC 2+ and FISH negative. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.

Study Timeline

• Study First Submitted: 2021-08-22
• Study First Submitted QC: 2021-08-22
• Study First Posted: 2021-08-24
• Study Start: 2021-10-20
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-25
• Primary Completion: 2022-12-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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;
• Plan to receive major surgical treatment within 2 weeks before first dose or during the trial period, or have suffered severe traumatic injury;
• Pregnancy or lactation;
• Unwilling or unable to use acceptable methods for contraception during the entire treatment period of this trial and within 8 months after the last dose;
• Participated in other clinical trials and used other experimental drugs within 4 weeks before the first dose;
• Any mental or cognitive impairment may limit their understanding and implementation of the informed consent form;
• Not suitable for participating in this trial, such as poor compliance.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARX788	ARX788	-

Primary Outcome Measures

Name	Time	Method
Objective remission rate (ORR)	2 years	ORR is defined as the percentage of subjects who have achieved complete response and partial response according RECIST 1.1

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	2 years	Overall survival (OS) is defined as the time from first dose of study therapy to the date of death (any cause). Subjects who are alive will be censored at the last known time that the subject was alive
Disease control rate (DCR)	2 years	Disease control rate (DCR) is defined as cases where objective remission (assessed as complete remission or partial remission according to RECIST 1.1 standard) or stable disease during the study
Duration of relief (DOR)	2 years	DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
Progression-free survival (PFS)	2 years	PFS is defined as the time between date of first dose of study therapy and date of progression or death, whichever occurs first, will be computed for response evaluable subjects. Subjects will be censored at time of subsequent therapy

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China