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.
Plain-language title generated from the registry record
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
Key facts
- Where
- Melbourne N. and Murdoch, AustraliaSee the 2 sites
- Phase
- Phase 1
Where in Australia
- Melbourne Theranostic Innovation CenterMelbourne N., AustraliaTaking people
- GenesisCare MurdochMurdoch, AustraliaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alpha-9 Oncology USA Inc.
- Trial code
- NCT07661641
- Record updated
- 4 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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.