HER2-positive biliary cancer
HER2 biliary cancer trial Australia: Early-phase now recruiting
A targeted, early-stage HER2 trial opens an option for a small, defined group of biliary cancer patients and requires precise selection and grounded expectations.
- Right patient, right trial, right expectations.
- If you are a match, it opens another option.
Steve HolmesOutline
This trial includes multiple cancer types. Biliary cancer is one subgroup being studied.
If you have confirmed HER2-positive disease and have already received at least one line of treatment, this may be an option to explore with your treating team.
Trial reference: NCT05523947
What this is
Biology
This trial targets HER2, a growth signal (A receptor protein) present on the cell’s surface in a minority of biliary cancers.
Physiology
The study drug (YH32367) is designed to block this signal and disrupt tumour growth.
Cognition (understanding)
This is a first-in-human Phase 1 and 2 trial.
Its primary purpose is to assess safety and dosing, with early signals of tumour response.
It also studies how the drug is processed in the body.
This is not a proven treatment.
How This Works
Biology (engine parts)
These are the key components the drug depends on:
HER2 expression level
How much HER2 is present on the cancer cell.
This is the key filter. High levels make this trial relevant.
HER2 receptor
The signal receiver on the cell surface that the drug attaches to.
Cell surface (membrane)
Where HER2 sits and where the drug must bind.
Growth signalling
The internal message that drives tumour growth when HER2 is active.
The Physiology (The engine in flow)
The Physiology of this drug:
YH32367 is a laboratory-made antibody protein given by infusion.
It is a real protein, similar to antibodies your body naturally makes, but designed to recognise a specific target. Antibodies are proteins your immune system uses to find and attach to things it needs to control or remove.
It is designed to find and attach to HER2, a protein receptor on the surface of some cells that receives growth signals.
In some tumours, HER2 is overexpressed. This means the cell receives too many growth signals, which can drive rapid growth.
By attaching to HER2, the drug blocks or interferes with these signals and may help slow tumour growth.
Who this is for
Patients must meet all of the following:
- Confirmed HER2-positive biliary tract cancer
- At least one measurable tumour on CT or MRI
- Have received at least one prior line of therapy
- Willing to undergo monitoring and possibly a biopsy
If you are unsure of your HER2 status, check your pathology report or speak with your oncologist.
Where this trial is available
Australian Sites
- Southern Oncology Clinical Research Unit, Adelaide
- Blacktown Hospital, Sydney
- Austin Health, Melbourne
Also recruiting in
- South Korea
- United States
Why this matters
For the right patient, this may open an additional pathway once standard treatments have been used.
However, this is an early-phase trial.
What that means
- Focus is on safety
- Benefit is not yet established
- Outcomes can vary
- Participation may contribute to future treatment development, with uncertain benefit to the individual.
What participation involves
Patients in this study will:
- Receive the investigational treatment
- Attend regular medical assessments
- Undergo blood tests and imaging such as CT scans
- Possibly provide tumour tissue for analysis
This trial does not replace standard medical care.
Participation is voluntary, and patients can withdraw at any time.
Start here
Review full trial details:
NCT05523947
Then discuss this option with your oncologist or contact a trial site directly.
Ethics and approvals
Australia – Regulatory authority
Approval Number: CT-2022-CTN-04880-1
Date: 03 Feb 2023
Southern Oncology Clinical Research Unit
IRB/HREC: Bellberry Limited
Approval Number: 2022-11-1239
Date: 31 Jan 2023
Blacktown Hospital
IRB/HREC: Bellberry Limited
Approval Number: 2022-11-1239
Date: 3 Jan 2023
Austin Health
IRB/HREC: Austin Health Human Research Ethics Committee
Approval Number: HREC/110580/Austin-2024
Date: 13 Jan 2025
Final position
This is a specific, early-stage trial for a defined biological subgroup.
It is not a general treatment pathway.
Used correctly, it helps the right patient explore an additional option.
Why We Are Here
Cancer becomes the way, not because we want it to, but because it leaves no alternative.
When cancer stands in the way, it becomes the way.
The question is not whether the obstacle of cancer exists.
It is whether we will use it to find a new way forward.
Clinical Trials provide new ways.
Written by Steve Holmes
Founder, Cholangiocarcinoma Foundation Australia
We are a patient-led community, built on a culture that functions as a survival system in itself.
Cholangiocarcinoma is not just a disease. It is the obstacle you must respond to.
What you do next determines the path.
That response becomes the way.
That is on you. Now.
Patient Response System
Journal. App. AI.
Patients shouldn’t be deprived of survival knowledge.
Most patients lose options not because of the cancer alone,
but because understanding comes too late.
We built the pathway to turn understanding into early action so that options won’t be lost.
The Patient Navigator Journal is how you start.
It is not a guide. It is a response system built from the lived experience of patients, caregivers, and clinicians.
It helps you know what to do, in the right order, when it matters most.
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