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Taking people in AustraliaPhase 1

Radioactive Drugs for Advanced Breast, Prostate and Colorectal Cancers With GRPR

Tests two radioactive drugs and imaging in adults with GRPR-positive advanced solid tumors.

Key facts

Who runs it
Alpha-9 Oncology USA Inc.
Where
Melbourne N. and Murdoch, AustraliaSee the 2 sites
Trial code
Registry title
A Study of [177Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642 With [68Ga]Ga-A9-6217 or [177Lu]Lu-A9-0631 Imaging in GRPR+ Solid Tumors
Status
Recruiting
Phase
Phase 1
People taking part
115 people, planned
Started
1 Jul 2026
Expected to end
Dec 2029
Type of study
Interventional, 2 groups
Treatments tested
  • [68Ga]Ga-A9-6217
  • Low dose [177Lu]Lu-A9-0631
  • [177Lu]Lu-A9-0631
  • [225Ac]Ac-A9-0642
Record updated
4 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced prostate, HR+/HER2- breast or colorectal cancer, or other GRPR-positive solid tumors, whose scans show GRPR on the tumor.

Age
18 years or older
Sex
All sexes can join
Disease stage
Locally advanced or metastatic tumor, with at least one measurable lesion (RECIST v1.1). Tumor types: prostate cancer, HR+/HER2- breast cancer, colorectal cancer, or GRPR-positive solid tumors. ECOG performance status 0 to 1.
Earlier treatment
The cancer got worse on standard local treatment, or the person could not take it or could not get it. At least 4 weeks since major surgery.
Biomarker or test result
GRPR-expressing disease confirmed by PET/CT or SPECT imaging

Main reasons for not taking part

  • Anticancer treatment within 14 days before the study drug (28 days for checkpoint inhibitors and other antibody therapies)
  • Allergy or known hypersensitivity to a peptide-based imaging or therapeutic agent, or its ingredients
  • Major surgery within 4 weeks of the first dose
  • Earlier external beam radiation to more than 25% of the bone marrow
  • Pregnant, breastfeeding, unwilling to use birth control, or any active infection

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Any active infection
  • Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study

Where in Australia

  • Melbourne Theranostic Innovation CenterMelbourne N., AustraliaContact: Prof. Rod HicksTaking people
  • GenesisCare MurdochMurdoch, AustraliaContact: Prof. Joe CardaciNot yet recruiting

About the trial

What the trial wants to find out

This is a Phase 1-1b multicenter clinical study to evaluate the safety, efficacy, and dosimetry of [177Lu]Lu-A9-0631 and [225Ac]Ac-0642 in participants with Gastrin-Releasing Peptide Receptor (GRPR) expressing locally advanced, unresectable or metastatic solid tumors.

The 2 groups in the trial

  • Phase 1 Dose EscalationTreatment being tested

    Treatment: [68Ga]Ga-A9-6217, Low dose [177Lu]Lu-A9-0631, [177Lu]Lu-A9-0631, and [225Ac]Ac-A9-0642

  • Phase 1B Dose ExpansionTreatment being tested

    Treatment: [68Ga]Ga-A9-6217, Low dose [177Lu]Lu-A9-0631, [177Lu]Lu-A9-0631, and [225Ac]Ac-A9-0642

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 1-1b Study to Evaluate the Safety, Efficacy, and Dosimetry of [177Lu]Lu-A9-0631, [225Ac]Ac-A9-0642, and [68Ga]Ga-A9-6217 in Participants With GRPR+ Tumors
Plain-language title
Radioactive Drugs for Advanced Breast, Prostate and Colorectal Cancers With GRPRGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
4 September 2026