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Also known as [Ac-225]-PSMA-62 (mCRPC)
PSMA-62 · 1 trial · 4 indications
Phase Ia: Incidence of dose limiting toxicities (DLTs)
Phase 1b: Incidence and severity of treatment emergent adverse events (TEAEs)
Phase Ia: Incidence and severity of treatment emergent adverse events (TEAEs)
| Arm | Type | Description |
|---|---|---|
| OmHSPC | EXPERIMENTAL | Patients with prostate cancer and biochemical recurrence after definitive surgery or radiation therapy, with 1-5 PSMA-positive lesions, who have not yet initiated lifelong hormone therapy. |
| mCRPC | EXPERIMENTAL | Patients with PSMA-positive mCRPC who have prior treatment with at least one APRI and received taxane chemotherapy (or ineligible/refused); and received a maximum of 3 prior systemic therapy regimens in the mCRPC setting. |
| Name | Type | Description |
|---|---|---|
| [Ac-225]-PSMA-62 (mCRPC) | DRUG | Phase Ia: Administered intravenously per dose escalation scheme. Patients will receive a single dose of \[Ac-225\]-PSMA-62 on Day 1 of each 6-week cycle for up to 4 cycles. Phase Ib: Administered intravenously at MTD or one dose level below MTD. Patients will receive a single dose of \[Ac-225\]-PSMA-62 on Day 1 of each 6-week or 4-week cycle, for a total of 4 cycles. |
| [Ac-225]-PSMA-62 (OmHSPC) | DRUG | Phase Ia: Administered intravenously per dose escalation scheme. Patients will receive a single dose of \[Ac-225\]-PSMA-62 on Day 1 of each 8-week cycle for up to 2 cycles. Phase Ib: Administered intravenously at MTD or one dose level below MTD. Patients will receive a single dose of \[Ac-225\]-PSMA-62 on Day 1 of each 8-week cycle, for a total of 2 cycles. |
Inclusion Criteria: 1. Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate 2. ECOG performance status 0 to 1 3. Criteria specific for patients with mCRPC: 1. Previously received an androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy...
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PSMA-62 is an investigational small molecule radiopharmaceutical being developed for prostate cancer. It is labeled with actinium-225, written as [Ac-225]-PSMA-62, and is designed to deliver radiation to prostate cancer cells. It is in Phase 1 clinical development and is not yet approved.
PSMA-62 is being studied in prostate cancer, including metastatic castration-resistant prostate cancer, oligometastatic prostate carcinoma, and hormone sensitive prostate cancer. The Phase 1 trial enrolls adults 18 years and older with these prostate cancer types. It remains investigational and has not been approved for any use.
PSMA-62 targets PSMA, or prostate-specific membrane antigen, a protein expressed on prostate cancer cells. The drug is a small molecule labeled with actinium-225, an alpha-emitting isotope, so targeting PSMA allows radiation delivery to PSMA-expressing tumor cells. The trial is biomarker selected for PSMA.
PSMA-62 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the ongoing Phase 1 study of the actinium-225 labeled agent in prostate cancer.
PSMA-62 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulator. One Phase 1 trial is active and not recruiting, with no completed trials reported for this asset.
PSMA-62 is being studied in the Phase 1 trial NCT06229366, titled [Ac-225]-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer. The trial is active but not recruiting, plans to enroll 142 participants, is controlled, and is being conducted in Canada.
Yes. PSMA-62 and [Ac-225]-PSMA-62 refer to the same investigational agent. The bracketed form, [Ac-225]-PSMA-62, specifies the actinium-225 radiolabel attached to the PSMA-targeting small molecule. The trial listing for metastatic castration-resistant prostate cancer uses the [Ac-225]-PSMA-62 name.