Active — Not RecruitingPhase 1

Study of 225Ac-PSMA-617 in Men With PSMA-positive Prostate Cancer

Australia, South Africa101 participantsStarted 2021-04-01

Plain-language summary

This is a Phase 1, open-label, international, dose escalation study to evaluate the safety of \[225Ac\]Ac-PSMA-617 (225Ac-PSMA-617) in men with PSMA-positive prostate cancer who have and have not had prior exposure to \[177Lu\]Lu-PSMA-617 (177Lu-PSMA-617) or \[177Lu\]Lu-PSMA I\&T (177Lu-PSMA I\&T).

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. PSA progression: minimum of two rising PSA values from a baseline measurement with an interval of \>= 1 week between each measurement. 2.0 ng/mL is the minimal starting value if PSA rise is only indication of progression.
✓. Soft tissue or visceral disease progression as per RECIST 1.1 criteria: increase \>= 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions.
✓. Bone progression: \>= 2 new lesions on bone scan.

What they're measuring

Recommended Phase 2 Dose (RP2D)

Timeframe: 6 weeks post Cycle 1 Day 1 (C1D1) of each dosing cohort through enrollment completion, an average of 1.5 years to determine RP2D

Trial details

NCT IDNCT04597411

SponsorEndocyte

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01-01

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