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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Phase 1-1b: Incidence of Adverse Events by Frequency, Duration, and Severity — From the first dose of study drug up to the End of Treatment (30 days after the last dose) An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of patients experiencing an AE in Part 1 will be reported.
Phase 1: Number of Patients with Dose-Limiting Toxicities (DLTs). — Up to 28 days following first study treatment DLTs is defined as any predefined AE occurring during the DLT observation period.
Phase 1: Maximum tolerated dose (MTD) — Up to 28 days following first study treatment Incidence of dose-limiting toxicity (DLT) per dose level of \[177Lu\]Lu-A9-0631 and/or \[225Ac\]Ac-A9-0642.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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