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PSMA-62

Phase 1

Prostate Cancer | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Dec 22, 2025

Target and mechanism

ModalitySmall molecule

Also known as [Ac-225]-PSMA-62 (mCRPC)

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment142

FDA Designations

No designations recorded

Clinical trial landscape

PSMA-62 · 1 trial · 4 indications

Phase 1 1
NCT06229366[Ac-225]-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate CancerProstate Cancer
ACTIVE NOT_RECRUITING142 Analytics
PHASE1ACTIVE NOT_RECRUITING
[Ac-225]-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum tolerated dose (MTD)
From first dose of study drug through end of DLT period (4 weeks)

Phase Ia: Incidence of dose limiting toxicities (DLTs)

Safety, tolerability, and Recommended Phase II Dose (RP2D)
From first dose of study drug through end of treatment (~16 - 24 weeks)

Phase 1b: Incidence and severity of treatment emergent adverse events (TEAEs)

Safety and tolerability
From first dose of study drug through end of treatment (~16 - 24 weeks)

Phase Ia: Incidence and severity of treatment emergent adverse events (TEAEs)

Secondary Endpoints

The incidence of treatment emergent adverse events as assessed per CTCAE v5.0
From first dose of study drug through end of study (~5 years)
Time to initiation of any life-long ADT, or other systemic hormonal therapies for prostate cancer
From first dose of study drug through end of study (~5 years)
Absorbed dose estimates (Gy) in normal organs
From first dose of study drug through end of treatment (~16 - 24 weeks)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
OmHSPCEXPERIMENTALPatients 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.
mCRPCEXPERIMENTALPatients 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.

Interventions

NameTypeDescription
[Ac-225]-PSMA-62 (mCRPC)DRUGPhase 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)DRUGPhase 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

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...

Countries:Canada
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Competitive Landscape -Prostate Cancer 254 trials

Frequently asked questions about PSMA-62

What is PSMA-62 used for?

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.

What does PSMA-62 target?

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.

Who makes PSMA-62?

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.

What phase is PSMA-62 in?

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.

What clinical trials is PSMA-62 in?

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.

Is PSMA-62 the same as [Ac-225]-PSMA-62?

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.