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Radioactive 'Smart Bombs' target Hard-to-Treat cancers

NCT ID NCT07661641

Disease control Sponsor: Alpha-9 Oncology USA Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This early-phase trial tests two radioactive drugs, [177Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642, in people with advanced solid tumors that have a protein called GRPR on their surface. These cancers include certain breast, prostate, and colorectal cancers that have stopped responding to standard therapies. The study aims to find safe doses and check how the drugs spread in the body, using a third diagnostic agent to identify GRPR-positive tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lutetium-177 and Actinium-225 attached to a molecule that targets GRPR
What this could lead to
If successful, this could provide a new targeted radiation therapy option for people with advanced GRPR-positive cancers that have stopped responding to standard treatments.
What could go wrong
This is a very early (Phase 1) trial, so the main goal is safety and dosing, not yet proving effectiveness. The radioactive drugs may cause side effects in healthy organs, and the trial is small, so results may not apply to all patients.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 115 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm colorectal cancer colorectal neoplasm hormone receptor-positive breast cancer prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Colorectal cancer GRPR-positive solid tumors Prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • GenesisCare Murdoch

    NOT_YET_RECRUITING

    Murdoch, Western Australia, 6150, Australia

  • Melbourne Theranostic Innovation Center

    RECRUITING

    Melbourne N., Victoria, 3051, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.