HER2-positive, Metastatic Breast CancerPhase 2NCT05018702
ARX788 in HER2-positive Breast Cancer Patients With Brain Metastases
A Phase 2 study testing ARX788 in people with HER2-positive, Metastatic Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
A Phase 2 Study of ARX788 in HER2-positive, Metastatic Breast Cancer Patients whose Disease is resistant or refractory to Tyrosine kinase inhibitors (TKI). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HER2-positive, Metastatic Breast Cancer
- 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
- 32 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 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
- Age ≥18 years, and ≤75 years, male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0~2;
- Breast cancer patients diagnosed as HR arbitrary/HER2-positive by pathological examination;
- Metastatic breast cancer subjects previously treated with trastuzumab, taxane and EGFR-TKI-containing regimens;
- MRI confirmed brain metastasis with at least one intracranial parenchymal untreated metastatic lesion;
- Mannitol, bevacizumab, or hormone therapy is allowed before enrollment;
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- Adequate organ functions;
- Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade ≤1.
- Patients who participate in the trial voluntarily, sign an informed consent, have good compliance and are willing to comply with the follow-up visit.
Who cannot join
- Pneumomeningeal metastases or cystic metastases confirmed by MRI or lumbar puncture;
- Uncontrolled third space effusion;
- Previous treatment with T-DM1 or other HER2-ADC drugs;
- Received a whole-brain radiotherapy, chemotherapy, or surgery within 2 weeks prior to the first dose of ARX788, or trastuzumab-targeted therapy or endocrine therapy within 1 week, or palliative radiotherapy for bone metastases within 2 weeks;
- 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;
- Participated in other clinical trials within 2 weeks prior to enrollment;
- Receiving any antitumor therapy for any other tumor, bevacizumab for the control of brain edema and bisphosphonates for the treatment of bone metastases or the prevention of osteoporosis are the exception;
- With a history of any malignancies other than breast cancer in the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin;
- Cardiac insufficiency;
- Uncontrolled hypertension;
- 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;
- Pregnancy or lactation;
- History of immunodeficiency, including HIV-positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
- Current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus or syphilis;
- History of neurological or psychiatric disorder, including epilepsy or dementia;
- Suffering severe or uncontrolled systemic diseases.
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 Prospective, Single-arm, Single-center Phase II Clinical Study of Recombinant Humanized Anti-HER2 Monoclonal Antibody-AS269 Conjugate (ARX788) in the Treatment of HER2-positive Breast Cancer Patients With Brain Metastases
A Phase 2 Study of ARX788 in HER2-positive, Metastatic Breast Cancer Patients whose Disease is resistant or refractory to Tyrosine kinase inhibitors (TKI).
Read the detailed description
This is an open-label, single arm, phase 2 study of ARX788 in HER2-positive, metastatic breast cancer patients whose disease is resistant or refractory to TKI. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion. In this study, Simon's two-stage design is used. Subjects received treatment until disease progression, intolerable toxicity, withdrawal from the study, or discontinuation judged by the investigator. Drug efficacy and safety data will be collected.
- Conditions
- HER2-positive, Metastatic Breast Cancer
- Being tested
- ARX788
- Keywords
- ARX788, HER2-positive breast cancer, Brain metastasis
- Medical subject headings
- Breast Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARX788Drug
1.5 mg/kg 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.
Central nervous system (CNS) clinical benefit rate (CBR)
CNS CBR is defined as the percentage of subjects who have achieved complete response, partial response, and stable disease according to the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria
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
Site of first progression
Record the organs where the disease first progressed during the study
Measured: 2 years
The number of subjects experiencing adverse events
Patient safety and adverse events (AEs) will be evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0. All AEs and serious adverse events (SAEs) will be assessed to determine the safety and tolerability of the treatment.
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 start14 Jul 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HER2-positive, Metastatic Breast CancerStudies 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
- 32 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
- NCT05018702
- Sponsor's protocol ID
- ACE-Breast-06
- Status last verified
- May 2022
- First submitted
- 22 Aug 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li T, Lin M, Wang B, Zhao M, Cao J, Wang L, Tao Z, Jin J, Miao H, Gong C, Zhao Y, Peng W, Hu X, Zhang J. Efficacy and safety of ARX788 for individuals with HER2-positive breast cancer and brain metastases (ACE-Breast-06): a single-arm, phase 2 trial in China. EClinicalMedicine. 2025 Oct 30;90:103614. doi: 10.1016/j.eclinm.2025.103614. eCollection 2025 Dec.
PubMed 41245540
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Single-center Phase II Clinical Study of Recombinant Humanized Anti-HER2 Monoclonal Antibody-AS269 Conjugate (ARX788) in the Treatment of HER2-positive Breast Cancer Patients With Brain Metastases
- ClinicalTrials.gov ID
- NCT05018702
- Acronym / sponsor ID
- ACE-Breast-06
- Conditions
- HER2-positive, Metastatic Breast Cancer
- Keywords
- ARX788, HER2-positive breast cancer, Brain metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 14 Jul 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 HER2-positive, Metastatic Breast Cancer Patients whose Disease is resistant or refractory to Tyrosine kinase inhibitors (TKI).
Detailed description
This is an open-label, single arm, phase 2 study of ARX788 in HER2-positive, metastatic breast cancer patients whose disease is resistant or refractory to TKI. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion. In this study, Simon's two-stage design is used. Subjects received treatment until disease progression, intolerable toxicity, withdrawal from the study, or discontinuation judged by the investigator. Drug efficacy and safety data will be collected.
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 (9 listed)
- Age ≥18 years, and ≤75 years, male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0~2;
- Breast cancer patients diagnosed as HR arbitrary/HER2-positive by pathological examination;
- Metastatic breast cancer subjects previously treated with trastuzumab, taxane and EGFR-TKI-containing regimens;
- MRI confirmed brain metastasis with at least one intracranial parenchymal untreated metastatic lesion;
Key exclusion criteria (18 listed)
- Pneumomeningeal metastases or cystic metastases confirmed by MRI or lumbar puncture;
- Uncontrolled third space effusion;
- Previous treatment with T-DM1 or other HER2-ADC drugs;
- Received a whole-brain radiotherapy, chemotherapy, or surgery within 2 weeks prior to the first dose of ARX788, or trastuzumab-targeted therapy or endocrine therapy within 1 week, or palliative radiotherapy for bone metastases within 2 weeks;
- 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 mg/kg IV infusion on Day 1 of each 21-day treatment cycle. | Drug | ARX788 |
Primary outcome
Central nervous system (CNS) clinical benefit rate (CBR)
Time frame: 2 years
CNS CBR is defined as the percentage of subjects who have achieved complete response, partial response, and stable disease according to the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria
4 secondary outcomes
Progression-free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Site of first progression
Time frame: 2 years
The number of subjects experiencing adverse events
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 1 Jun 2022.
- Derived from this study: PubMed 41245540Li T, Lin M, Wang B, Zhao M, Cao J, Wang L, Tao Z, Jin J, Miao H, Gong C, Zhao Y, Peng W, Hu X, Zhang J. Efficacy and safety of ARX788 for individuals with HER2-positive breast cancer and brain metastases (ACE-Breast-06): a single-arm, phase 2 trial in China. EClinicalMedicine. 2025 Oct 30;90:103614. doi: 10.1016/j.eclinm.2025.103614. eCollection 2025 Dec.
- 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 HER2-positive, Metastatic Breast Cancer, 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 9 inclusion and 18 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 1 Jun 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 (86-18121299346, cinderellaliting@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central nervous system (CNS) clinical benefit rate (CBR) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05018702, which also lists 1 linked publication.
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 1 Jun 2022.