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
About this study
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.
- Condition
- Breast Cancer, Prostate Cancer, Colorectal Cancer, GRPR-positive Solid Tumors
- Tested
- [68Ga]Ga-A9-6217, Low dose [177Lu]Lu-A9-0631, [177Lu]Lu-A9-0631, [225Ac]Ac-A9-0642
- Sponsor
- Alpha-9 Oncology USA Inc.
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 10
- Minimum age: 18 years
- Study condition: Breast Cancer, Prostate Cancer, Colorectal Cancer, GRPR-positive Solid Tumors
- 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 6
- 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.
Where
2 sites, 2 recruiting
Melbourne Theranostic Innovation Center
Melbourne N., Victoria, Australia
GenesisCare Murdoch
Murdoch, Western Australia, Australia
Contact
-
Stephen Hull, MD
+1-778-715-3303 shull@a9oncology.com
Potential match only. Final eligibility is determined by the study team.