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ARX788 in Breast Cancer With Low Expression of HER2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05018676
Recruitment Status : Unknown
Verified April 2022 by Xichun Hu, Fudan University.
Recruitment status was:  Recruiting
First Posted : August 24, 2021
Last Update Posted : April 25, 2022
Sponsor:
Information provided by (Responsible Party):
Xichun Hu, Fudan University

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

Condition or disease Intervention/treatment Phase
Breast Cancer With Low Expression of HER2 Drug: ARX788 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm, Single-center Phase II Clinical Study of Recombinant Humanized Anti-HER2 Monoclonal Antibody-AS269 Conjugate (ARX788) in the Treatment of Unresectable and/or Metastatic Breast Cancer With Low Expression of HER2
Actual Study Start Date : October 20, 2021
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: ARX788 Drug: ARX788
1.5 mgkg IV infusion on Day 1 of each 21-day treatment cycle.




Primary Outcome Measures :
  1. Objective remission rate (ORR) [ Time Frame: 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 :
  1. Progression-free survival (PFS) [ Time Frame: 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

  2. Overall survival (OS) [ Time Frame: 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

  3. Disease control rate (DCR) [ Time Frame: 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

  4. Duration of relief (DOR) [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05018676


Contacts
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Contact: Ting Li +8618121299346 cinderellaliting@126.com

Locations
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China
Fudan University Shanghai Cancer Center Recruiting
Shanghai, China, 200032
Contact: Ting Li, M.D., Ph.D.    86-18121299346    cinderellaliting@126.com   
Sponsors and Collaborators
Fudan University
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Responsible Party: Xichun Hu, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT05018676    
Other Study ID Numbers: ACE-Breast-07
First Posted: August 24, 2021    Key Record Dates
Last Update Posted: April 25, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xichun Hu, Fudan University:
ARX788
Breast cancer
Low expression of HER2
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases