Breast CancerPhase 2NCT06578286
ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd
A Phase 2 study testing ARX788 in people with Breast Cancer, run by Fudan University.
Trial summary
A single arm, phase 2 Study of ARX788 in HER2-positive metastatic breast cancer patients who were previously treated with T-DXd. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- 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
- 44 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2024to 30 Sep 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- 18 to 75 years old (including upper and lower limits), male or female;
- Unresectable locally advanced, recurrent or metastatic BC;
- Tissue samples determined to be HER2 positive (defined as IHC3+ or FISH+);
- Received T-DXd treatment in the advanced stage;
- Adequate bone marrow, liver, kidney and coagulation function;
- Voluntarily sign the informed consent, have good compliance and are willing to comply with the follow-up visit.
Who cannot join
- With meningeal metastases or disseminated brain metastases or active brain metastases;
- Has interstitial lung disease requiring steroid therapy, a history of drug-induced interstitial lung disease, a history of radiation pneumonitis, or any evidence indicating clinically active interstitial lung disease;
- Has any eye disease that require medical intervention such as keratitis, corneal diseases or active eye infection;
- Has cardiac insufficiency;
- Has received any systemic anti-tumor therapy (with the exception of endocrine therapy, with an interval of at least 7 days) within 28 days (or at least 5 half-lives) before the first use of the investigational product;
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluate the Efficacy and Safety of ARX788 in Patients With HER2-positive Advanced Breast Cancer Whose Disease Has Progressed Following T-DXd Therapy
A single arm, phase 2 Study of ARX788 in HER2-positive metastatic breast cancer patients who were previously treated with T-DXd. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.
- Conditions
- Breast Cancer
- Being tested
- ARX788
- 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
ARX788，1.5 mg/kg IV infusion on Day 1 of each 21-day treatment cycle
| Study group | Role | What they receive |
|---|---|---|
| ARX788 | Experimental | ARX788，1.5 mg/kg IV infusion on Day 1 of each 21-day treatment cycle Receives: Drug: ARX788 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective remission rate (ORR)
The proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1.
Measured: Until progression, assessed up to approximately 24 months
Secondary outcomes (5)
Disease control rate (DCR)
The proportion of patients who have a CR or PR or SD, as determined by the Investigator at local site per RECIST 1.1.
Measured: Baseline through end of study, assessed up to 24 months]
Duration of relief (DOR)
Time from the date of first documented response until the date of documented progression or death in the absence of disease progression
Measured: Until progression, assessed up to approximately 24 months
Progression-free survival (PFS)
Time to progression as assessed by the Investigator at local site per RECIST 1.1, or death due to any cause.
Measured: Until progression or death, assessed up to approximately 36 months]
Overall survival (OS)
Time to death due to any cause
Measured: Until death, assessed up to approximately 50 months
The number of subjects experiencing adverse event TEAEs
Occurrence of AEs according to CTCAE v5.0
Measured: Up to follow-up period, approximately 50 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start30 Sep 2024 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhang,MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578286
- Sponsor's protocol ID
- ACE-Breast-10
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Efficacy and Safety of ARX788 in Patients With HER2-positive Advanced Breast Cancer Whose Disease Has Progressed Following T-DXd Therapy
- ClinicalTrials.gov ID
- NCT06578286
- Acronym / sponsor ID
- ACE-Breast-10
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 29 Aug 2024 (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 single arm, phase 2 Study of ARX788 in HER2-positive metastatic breast cancer patients who were previously treated with T-DXd. 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: ARX788ARX788，1.5 mg/kg IV infusion on Day 1 of each 21-day treatment cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 to 75 years old (including upper and lower limits), male or female;
- Unresectable locally advanced, recurrent or metastatic BC;
- Tissue samples determined to be HER2 positive (defined as IHC3+ or FISH+);
- Received T-DXd treatment in the advanced stage;
- Adequate bone marrow, liver, kidney and coagulation function;
Key exclusion criteria (5 listed)
- With meningeal metastases or disseminated brain metastases or active brain metastases;
- Has interstitial lung disease requiring steroid therapy, a history of drug-induced interstitial lung disease, a history of radiation pneumonitis, or any evidence indicating clinically active interstitial lung disease;
- Has any eye disease that require medical intervention such as keratitis, corneal diseases or active eye infection;
- Has cardiac insufficiency;
- Has received any systemic anti-tumor therapy (with the exception of endocrine therapy, with an interval of at least 7 days) within 28 days (or at least 5 half-lives) before the first use of the investigational product;
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 |
|---|---|---|
| ARX788ARX788，1.5 mg/kg IV infusion on Day 1 of each 21-day treatment cycle | Drug | ARX788 |
Primary outcome
Objective remission rate (ORR)
Time frame: Until progression, assessed up to approximately 24 months
The proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1.
5 secondary outcomes
Disease control rate (DCR)
Time frame: Baseline through end of study, assessed up to 24 months]
Duration of relief (DOR)
Time frame: Until progression, assessed up to approximately 24 months
Progression-free survival (PFS)
Time frame: Until progression or death, assessed up to approximately 36 months]
Overall survival (OS)
Time frame: Until death, assessed up to approximately 50 months
The number of subjects experiencing adverse event TEAEs
Time frame: Up to follow-up period, approximately 50 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARX788 in people with Breast Cancer, run by Fudan University.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Zhang, MD,PhD (+8664175590 ext. 85000, syner2000@163.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: Until progression, assessed up to approximately 24 months). 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 29 Aug 2024.