NCT07661641RecruitingPhase 1
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
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
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 115 (estimated)
- First submitted
- 9 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Alpha-9 Oncology USA Inc.
- Diseases
- Prostate cancer, Colorectal cancer
- NCT number
- NCT07661641
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 115
- From 1 Jul 2026 to the primary completion date, Dec 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Any active infection.
Other
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Melbourne Theranostic Innovation Center Coordinator of this site? Confirm its status | Melbourne N. | Australia | Recruiting |
| GenesisCare Murdoch Coordinator of this site? Confirm its status | Murdoch | Australia | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.