Breast Cancer With Low Expression of HER2Phase 2NCT05018676
ARX788 in Breast Cancer With Low Expression of HER2
A Phase 2 study testing ARX788 in people with Breast Cancer With Low Expression of HER2, run by Fudan University at 1 site in China.
Trial summary
A Phase 2 Study of ARX788 in unresectable and/or metastatic breast cancer with low expression of HER2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer With Low Expression of HER2
- What is being tested?
- ARX788
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2021to 30 Jun 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Ting Li, M.D., Ph.D., 86-18121299346, cinderellaliting@126.com
About this study
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
A Phase 2 Study of ARX788 in unresectable and/or metastatic breast cancer with low expression of HER2.
Read the 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.
- Being tested
- ARX788
- Keywords
- ARX788, Breast cancer, Low expression of HER2
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARX788Drug
1.5 mgkg IV infusion on Day 1 of each 21-day treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| ARX788 | Experimental | Not described Receives: Drug: ARX788 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective remission rate (ORR)
ORR is defined as the percentage of subjects who have achieved complete response and partial response according RECIST 1.1
Measured: 2 years
Secondary outcomes (4)
Progression-free survival (PFS)
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
Measured: 2 years
Overall survival (OS)
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
Measured: 2 years
Disease control rate (DCR)
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
Measured: 2 years
Duration of relief (DOR)
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start20 Oct 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer With Low Expression of HER2Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xichun Hu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018676
- Sponsor's protocol ID
- ACE-Breast-07
- Status last verified
- Apr 2022
- First submitted
- 22 Aug 2021
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05018676
- Acronym / sponsor ID
- ACE-Breast-07
- Keywords
- ARX788, Breast cancer, Low expression of HER2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARX788 | Experimental | Drug: ARX788 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARX7881.5 mgkg IV infusion on Day 1 of each 21-day treatment cycle. | Drug | ARX788 |
Primary outcome
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
4 secondary outcomes
Progression-free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Disease control rate (DCR)
Time frame: 2 years
Duration of relief (DOR)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARX788 in people with Breast Cancer With Low Expression of HER2, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting Li (+8618121299346, cinderellaliting@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective remission rate (ORR) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.