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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 being developed for the treatment of prostate cancer, including metastatic castration-resistant prostate cancer, oligometastatic prostate carcinoma, and hormone-sensitive prostate cancer. It is currently being studied in a Phase 1 clinical trial.
PSMA-62 targets prostate-specific membrane antigen (PSMA), a protein highly expressed on prostate cancer cells. By binding to PSMA, the drug is designed to deliver a radioactive payload, actinium-225, directly to cancer cells, potentially damaging their DNA and killing them.
PSMA-62 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is currently in Phase 1 clinical development.
PSMA-62 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in clinical trials.
PSMA-62 is being studied in a Phase 1 clinical trial with the identifier NCT06229366. This trial is active but not recruiting participants, and it is enrolling approximately 142 patients in Canada with prostate cancer, including metastatic castration-resistant prostate cancer and oligometastatic prostate carcinoma.
Yes, PSMA-62 is also known as [Ac-225]-PSMA-62, particularly in the context of metastatic castration-resistant prostate cancer (mCRPC). The name reflects the drug's composition, which includes the radioactive isotope actinium-225 attached to a PSMA-targeting molecule.