NCT07661641 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
| NCT ID | NCT07661641 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Alpha-9 Oncology USA Inc. |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 115 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 115 participants in total. It began in 2026-07-01 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Stephen Hull, MD
STUDY DIRECTOR
Alpha 9 Oncology
Frequently Asked Questions
Who can join the NCT07661641 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07661641 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07661641 currently recruiting?
Yes, NCT07661641 is actively recruiting participants. Contact the research team at shull@a9oncology.com for enrollment information.
Where is the NCT07661641 trial being conducted?
This trial is being conducted at Melbourne N., Australia, Murdoch, Australia.
Who is sponsoring the NCT07661641 clinical trial?
NCT07661641 is sponsored by Alpha-9 Oncology USA Inc.. The principal investigator is Stephen Hull, MD at Alpha 9 Oncology. The trial plans to enroll 115 participants.
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