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

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

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.

Conditions5

Interventions2

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