Can a Six-Weekly targeted drug shrink HER2-Positive breast tumors?
NCT ID NCT06663748
First seen Oct 16, 2026 · Last updated Oct 16, 2026
Summary
Researchers are testing a drug called ARX788 in people with HER2-positive breast cancer that has spread or cannot be removed by surgery. The study gives ARX788 as an intravenous infusion every six weeks. The main goal is to see how many participants see their tumors shrink or disappear. The trial includes up to 44 adults who have had limited prior chemotherapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ARX788, an experimental antibody-drug conjugate that targets HER2
- What this could lead to
- If it works, this could offer a less frequent treatment option for people with HER2-positive advanced breast cancer.
- What could go wrong
- The trial is small and early, so results may not hold in larger studies. ARX788 can cause side effects, and it may not shrink tumors for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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; * 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. Exclusion Criteria: * 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; * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Henan Cancer Hospital
RECRUITINGZhengzhou, Henan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Triple drug combo targets HER2-Positive breast cancer
- Can an immune booster revive a stalled breast cancer drug?
- Some metastatic breast cancer patients may be able to halt years of HER2 treatment
- Can a Two-Drug combo overcome resistance in HER2-Positive breast cancer?
- Can a new drug combo outsmart breast cancer that resists current therapy?
- Can a platform trial match the right drug combo to each tumor?