Overview

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.