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 Alpha-9 Oncology USA Inc.
Registry number NCT07661641
Started 1 July 2026 Today 16 October 2026 Estimated completion 1 December 2028

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Melbourne Theranostic Innovation Center Melbourne N. VIC Recruiting
GenesisCare Murdoch Murdoch WA Not yet recruiting

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

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 115

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:

* Participant has provided written informed consent prior to any study-specific procedure.

* Age ≥ 18 years old.

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

* Have measurable target lesion per RECIST v1.1.

* Progression from, intolerant to, or ineligible for (due to unavailability or contraindication) local standard of care therapies and have one of the following locally advanced or metastatic tumor types: prostate cancer; HR+/HER2- breast cancer; colorectal cancer; and GRPR-positive solid tumors.

* Have GRPR-expressing disease as confirmed by PET / CT or SPECT imaging.

* Adequate organ function within 14 days of first administration of investigational therapeutic product.

* At least 4 weeks from prior major surgery.

Exclusion Criteria:

* Received anticancer treatment including but not limited to chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or experimental drugs ≤ 14 days prior (≤ 28 days prior in case of checkpoint inhibitor therapy and other antibody therapies) or 5 half-lives, (t1/2) whichever is shorter, to the administration of therapeutic investigational product.

* History of uncontrolled allergic reactions and/or known or expected hypersensitivity to a peptide-based imaging or therapeutic agent or any excipient present in either of the therapeutic investigational products.

* Major surgery within 4 weeks of planned first dose of the therapeutic investigational product.

* Prior external beam radiation therapy to more than 25% of the bone marrow.

* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.

* Any active infection.

Dates on the record

Started 1 July 2026
Estimated completion 1 December 2028
Registry last updated 4 September 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 4 September 2026.
  • 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.