HER2-positive, Metastatic Breast CancerPhase 2NCT06663748
ARX788 in HER2-positive Metastatic Breast Cancer Patients
A Phase 2 study testing ARX788 in people with HER2-positive, Metastatic Breast Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
A phase 2 study of ARX788 given every 6 weeks in HER2-positive, metastatic breast cancer patients. 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
- 44 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2025to 20 Nov 2029
- Phase
- Phase 2
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;
- Has previously received ≤ two lines of chemotherapy (excluding hormone therapy) for recurrent or metastatic BC;
- Tissue samples determined to be HER2 positive (defined as IHC3+ or FISH+);
- Has at least one measurable target lesion as per RECIST1.1 criteria;
- Has recovered from any AE (≤ Grade 1) related to prior surgery and prior cancer treatment;
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- Adequate bone marrow, liver, kidney and coagulation function;
- ECOG Performance Status Score of 0-1;
- Voluntarily sign the informed consent, have good compliance and are willing to comply with the follow-up visit.
Who cannot join
- Has known history to be allergic to any active ingredient or excipient of ARX788;
- With meningeal metastases or disseminated brain metastases or active brain metastases, who need radiation, surgery or drug therapy;
- Has pericardial effusion, pleural effusion or ascites effusion with clinical symptoms, signs or require symptomatic treatment;
- 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;
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- Uncontrolled hypertension;
- Has evidence of severe or uncontrollable systemic diseases;
- Received live vaccines within 4 weeks before the first use of the investigational product or plans to receive live vaccines during the trial;
- Breastfeeding female, or who has childbearing potential with a positive baseline pregnancy test or who is unwilling to use effective contraception during the trial;
- Is unwilling or unable to stop wearing corneal contact lens during the trial;
- 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;
- Has any mental or cognitive disorder that may restrict his/her understanding and execution of the informed consent form;
- Other conditions that the Investigator considers inappropriate for participation in this trial, such as poor compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Min Yan, Professor, +86 15713857388, ym200678@126.com
About this study
Official title: Evaluate the Efficacy and Safety of ARX788 Given Every 6 Weeks in Patients With HER2-positive Advanced Breast Cancer
A phase 2 study of ARX788 given every 6 weeks in HER2-positive, metastatic breast cancer patients.
Read the detailed description
A single arm, phase 2 study of ARX788 in HER2-positive, metastatic breast cancer patients. The ARX788 will be administered every 6 weeks (Q6W) intravenous (IV) infusion.
- Conditions
- HER2-positive, Metastatic Breast Cancer
- Being tested
- ARX788
- Keywords
- ARX788, HER2-positive breast cancer, Q6W
- 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
2.2 mg/kg IV infusion on Day 1 of each 42-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 participants in the analysis population who have CR or PR per RECIST 1.1.
Measured: up to 2 years
Secondary outcomes (15)
Disease control rate (DCR)
DCR is defined as the percentage of participants in the analysis population who have CR or PR or SD per RECIST 1.1.
Measured: up to 2 years
Duration of relief (DOR)
DOR is defined as the interval from response initiation (when either CR or PR is first determined) to progression or death, whichever occurs first.
Measured: From response initiation (when either CR or PR is first determined) to progression or death, whichever occurs first, assessed up to 2 years.
Progression-free survival (PFS)
PFS was defined as the time from first dose to first documented disease progression (PD) or death from any cause, whichever occurred first.
Measured: From first dose to first documented disease progression (PD) or death from any cause, whichever occurred first, assessed up to 2 years.
Overall survival (OS)
OS was defined as the time from the first dose of study drug to any-cause death.
Measured: From the date of first dose of study drug to any-cause death, assessed up to 5 years
The number of subjects experiencing adverse event TEAEs
Number of participants with TEAEs as assessed by CTCAE v5.0
Measured: up to 2 years
Pharmacokinetic parameter: Maximum concentration (Cmax)
Measured: At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Time to Cmax (tmax)
Measured: At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Terminal half-life (t1/2)
Measured: At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Area under the concentration-time curve from zero extrapolated to infinity [AUC(0-inf)]
Measured: At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Area under the concentration-time curve from zero to the last quantifiable concentration [AUC(0-last)]
Measured: At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Terminal rate constant (λz)
Measured: At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Systemic clearance (CL)
Measured: At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Volume of distribution (Vz)
Measured: At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Volume of distribution at steady state (Vss)
Measured: At the end of Cycle 3 (each cycle is 42 days)
Pharmacokinetic parameter: Trough concentration (Ctrough)
Measured: At the end of Cycle 3 (each cycle is 42 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start16 Jun 2025
- Primary completion20 Nov 2027 (estimated)
- Study completion20 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive, Metastatic Breast CancerStudies of the same condition, open and under way.
- 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
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Min Yan, MD, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663748
- Sponsor's protocol ID
- ACE-Breast-09
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No