Phase I Study of 225Ac-J591 Plus 177Lu-PSMA Small Molecule for Progressive Metastatic Castration Resistant Prostate Cancer

NCT04886986 Phase 1 ACTIVE_NOT_RECRUITING

This is a phase I dose-escalation study of 225Ac-J591 administered together with 177Lu-PSMA small molecule. Both drugs are designed to deliver radiation to prostate cancer cells; they are known as radionuclide conjugates (radiation linked to antibodies/molecules that recognize prostate cancer cells). This phase of the study (phase I) will determine the highest dose of the study intervention that can be safely given.

Details

Lead sponsor	Weill Medical College of Cornell University
Phase	Phase 1
Status	ACTIVE_NOT_RECRUITING
Enrolment	20
Start date	2021-06-30
Completion	2029-12

Conditions

• Prostate Cancer

Interventions

• 225Ac-J591
• 177Lu-PSMA-617
• 68Ga-PSMA-11
• 177Lu-PSMA-I&T

Primary outcomes

• Dose limiting toxicity (DLT) of 225Ac-J591 and 177Lu-PSMA small molecule — From Cycle 1 Day 1 up to 12 weeks after Cycle 1 Day 1 (each cycle is 8 weeks).
  DLTs will be measured by utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
• Cumulative maximum tolerated dose (MTD) or recommended phase II dose 225Ac-J591 and 177Lu-PSMA small molecule — From Cycle 1 Day 1 up to 12 weeks after Cycle 1 Day 1 (each cycle is 8 weeks).
  The dose that produces an "acceptable" level of toxicity or that, if exceeded, would put subjects at "unacceptable" risk for toxicity. Definition of the MTD usually relies on the sample, as MTD is defined as the dose level at which no more than one patient out of six experienced dose-limiting toxicity (DLT).
• Proportion of PSMA+ subjects (by imaging criteria) with >50% PSA decline following treatment with the combination of 225Ac-J591 and 177Lu-PSMA small molecule — From Cycle 1 Visit 1 up to end of study, approximately 3 years (each cycle is 8 weeks).
  Proportion of patients achieving 50% or greater PSA decline (relative to baseline/pre-treatment PSA). Response may occur at any time following treatment initiation and prior to going off study or initiation of new therapy.

Countries

United States