Phase 1 study

Recruiting Phase 1

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting

Phase Phase 1

Sponsor Akeso

Registry number NCT06730386

Started 24 February 2025 Today 16 October 2026 Estimated completion 26 February 2028

Where this trial is running

Trial sites and the status recorded for each
Site	City	State or country	Status at this site
Blacktown Hospital-Blacktwon Cancer and Haematology Centre	Blacktown	NSW	Not yet recruiting
Macquarie University	North Ryde	NSW	Not yet recruiting
ICON Cancer Centre South Brisbane	South Brisbane	QLD	Recruiting
Peninsula & South Eastern Haematology and Oncology Group	Frankston	VIC	Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years to 75 Years

Sex Anyone, regardless of sex

Healthy volunteers Not accepted

Enrolment target 100

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:

1. The subject must sign the written informed consent form (ICF) voluntarily;

2. At enrollment, aged ≥ 18 to ≤ 75 years, both males and females are eligible;

3. ECOG performance status score of 0 or 1;

4. Has a life expectancy of ≥ 3 months;

5. Subjects who have histologically or cytologically diagnosed locally advanced or metastatic solid tumor, which Is refractory to or intolerant to standard treatment;

6. At least 1 measurable lesion as per RECIST v1.1 that is suitable for repeated accurate measurement.

7. Adequate organ function.

Exclusion Criteria:

1. Prior human epidermal growth factor receptor 3 (HER3) -targeted therapies, including antibodies, antibody-drug conjugates (ADCs), chimeric antigen receptor T-cell immunotherapy (CAR-T), and others;

2. Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;

3. Presence of active central nervous system (CNS) metastases.

4. Patients with a history of non-infectious pneumonitis requiring systemic corticosteroid therapy; a history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis); currently suffering from ILD/pneumonitis or suspected of having such diseases based on imaging during screening;

5. Live vaccines or attenuated live vaccines administered within 4 weeks prior to the first dose, or planned to be administered during the study; use of inactivated vaccines is allowed;

6. Untreated subjects with active hepatitis B (HBsAg positive and HBV-DNA exceeding 1000 copies/mL (200 IU/mL) and above the lower limit of detection). For HBsAg-positive subjects, anti-hepatitis B therapy is required during the study; subjects with active hepatitis C (HCV antibody positive and HCV-RNA levels above the lower limit of detection) is also an exclusion;

7. Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease;

8. Active syphilis infection;

9. Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies;

10. Other reasons for ineligibility as evaluated by the investigator.

Dates on the record

Started 24 February 2025

Estimated completion 26 February 2028

Registry last updated 6 March 2025

Checked by Voxsanity 11 October 2026

Results, publications and the official record

No results are posted on the official record yet.
No publications are listed on the official record yet.
Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.

Sources and dates

ClinicalTrials.gov – the record this page reformats
ClinicalTrials.gov processing date: 6 March 2025.
This page last checked by Voxsanity: 11 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.

Voxsanity

Clinical trials recruiting in Australia, from the public registries · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial, which may be relevant to my care:

Trial: NCT06730386

Sponsor: Akeso

Phase: Phase 1

Status: Recruiting

More information: https://clinicaltrials.gov/study/NCT06730386

Eligibility criteria, as the registry published them

Reproduced exactly, unedited. Written for researchers rather than for patients.

Inclusion Criteria:

The subject must sign the written informed consent form (ICF) voluntarily;
At enrollment, aged ≥ 18 to ≤ 75 years, both males and females are eligible;
ECOG performance status score of 0 or 1;
Has a life expectancy of ≥ 3 months;
Subjects who have histologically or cytologically diagnosed locally advanced or metastatic solid tumor, which Is refractory to or intolerant to standard treatment;
At least 1 measurable lesion as per RECIST v1.1 that is suitable for repeated accurate measurement.
Adequate organ function.

Exclusion Criteria:

Prior human epidermal growth factor receptor 3 (HER3) -targeted therapies, including antibodies, antibody-drug conjugates (ADCs), chimeric antigen receptor T-cell immunotherapy (CAR-T), and others;
Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;
Presence of active central nervous system (CNS) metastases.
Patients with a history of non-infectious pneumonitis requiring systemic corticosteroid therapy; a history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis); currently suffering from ILD/pneumonitis or suspected of having such diseases based on imaging during screening;
Live vaccines or attenuated live vaccines administered within 4 weeks prior to the first dose, or planned to be administered during the study; use of inactivated vaccines is allowed;
Untreated subjects with active hepatitis B (HBsAg positive and HBV-DNA exceeding 1000 copies/mL (200 IU/mL) and above the lower limit of detection). For HBsAg-positive subjects, anti-hepatitis B therapy is required during the study; subjects with active hepatitis C (HCV antibody positive and HCV-RNA levels above the lower limit of detection) is also an exclusion;
Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease;
Active syphilis infection;
Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies;
Other reasons for ineligibility as evaluated by the investigator.

A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a registered health practitioner to access unapproved therapeutic goods for individual patients.

Not medical advice. Voxsanity reformats information published by public registries. It does not give medical advice and is not a substitute for talking to your doctor.