ACTinium in Castrate-RESistant Prostate Cancer After LUTEtium

Sponsor
University College, London
Study ID
NCT07414940
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Actinium (225Ac) rhPSMA-10.1 — DRUG
    Dose will vary depending on trial phase and dose escalation/de-escalation stage

Study Details

Advanced metastatic castration-resistant prostate cancer is a medical condition for which additional effective and tolerable treatments are urgently needed in order to improve patient outcomes and quality of life. The goal of this clinical trial is to learn more about Actinium (225Ac) radiohybrid prostate-specific membrane antigen-10.1 (rhPSMA-10.1) injection in men with prostate cancer that has spread and progressed after previous treatments, particularly after Lutetium-PSMA. Actinium (225Ac) rhPSMA-10.1 is an injectable radioactive medication that aims to attach to prostate cancer cells in the body and destroy them using ionising radiation. It is a new medication that has not yet been studied in humans. Participants will receive a dose of Actinium (225Ac) rhPSMA-10.1 every 6 weeks, to a maximum of 6 doses. They will be reviewed regularly by the trial researchers to monitor side effects and safety signals. A range of medication doses will be administered so that researchers can find out what doses of the medication are safe for men with prostate cancer. The trial will also aim to determine how effective this medication is for treating advanced prostate cancer.

Key Dates

First listed
Feb 17, 2026
Start date
Apr 13, 2026
Status verified
Apr 2026
Primary completion
Mar 30, 2031
Completion
Dec 30, 2031

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I dose escalation/de-escalation of Actinium (225Ac) rhPSMA-10.1
    Participants with advanced metastatic castration-resistant prostate cancer (mCRPC) will receive Actinium (225Ac) rhPSMA-10.1. The dose received by successive participants will be determined according to a pre-specified dose escalation/de-escalation scheme.
  • Experimental: Phase II cohort expansion at recommended Phase II dose
    Participants with advanced metastatic castration-resistant prostate cancer (mCRPC) will receive Actinium (225Ac) rhPSMA-10.1 at the recommended Phase II dose determined in Phase I.

Primary Outcome Measure

Phase I incidence of dose-limiting toxicities (DLTs) [ Time Frame: From time of IMP administration until completion of the dose-limiting toxicity period, which is 6 weeks. ]

Central Contacts

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