Phase 2 study

Recruiting Phase 2

Sources: ClinicalTrials.gov Checked: 12 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 2
Sponsor Bayer
Registry number NCT06760819
Started 13 February 2025 Today 16 October 2026 Estimated completion 2 February 2029

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
NSW Health - Blacktown Hospital Blacktown NSW Recruiting
Macquarie University Hospital - Oncology Department Sydney NSW Recruiting
ICON Cancer Centre - Southport Southport QLD Not yet recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 12 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 111

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

* Documented histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumor cancer (colorectal carcinoma; biliary tract cancer; bladder and urothelial tract cancer; cervical cancer; endometrial cancer; breast cancer; other solid tumor cancer, excluding NSCLC)

* Participant must be ≥18 years of age or over the legal age of consent

* Patients who have received prior standard therapy appropriate for their tumor type and stage of disease, or who have no satisfactory alternative treatments

* Documented activating HER2 mutation

* At least one measurable lesion that would qualify as a target lesion by RECIST 1.1 criteria

Exclusion Criteria:

* Primary diagnosis of non-small cell lung cancer (NSCLC)

* Prior treatment with a HER2 tyrosine kinase inhibitor (TKI)

* Active brain metastases

* Uncontrolled, severe, intercurrent illness

Dates on the record

Started 13 February 2025
Estimated completion 2 February 2029
Registry last updated 2 October 2026
Checked by Voxsanity 12 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 2 October 2026.
  • This page last checked by Voxsanity: 12 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.