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

Part of paid clinical trials in Brooklyn, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT04886986
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • 225Ac-J591 — DRUG
    30 - 40 KBq/kg (dose-escalation) every 8 weeks, for up to 2 cycles. Administered together with 177Lu-PSMA-617. Intravenous administration.
  • 177Lu-PSMA-617 — DRUG
    6.8 - 7.4 GBq received every 8 weeks, for up to 2 cycles. Administered together with 225Ac-J591. Intravenous administration.
  • 68Ga-PSMA-11 — DRUG
    \[185 ±74 MBq or 5 ±2 mCi\] intravenous during screening, 12 weeks, 24 weeks. Imaging agent for PSMA PET/CT.
  • 177Lu-PSMA-I&T — DRUG
    6.8 GBq received every 8 weeks, up to 2 cycles. Administered together with 225Ac-J591. Intravenous administration.

Study Details

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.

Key Dates

Start date
Jun 30, 2021
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
42 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination of 225Ac-J591 and 177Lu-PSMA-I&T
    Participants who received the combination of 225Ac-J591 and 177Lu-PSMA-I\&T, along with 68Ga-PSMA-11.
  • Experimental: Combination of 225Ac-J591 and 177Lu-PSMA-617
    Participants will receive the study drugs 225Ac-J591 and 177Lu-PSMA-617, along with 68Ga-PSMA-11.

Primary Outcome Measure

Dose limiting toxicity (DLT) of 225Ac-J591 and 177Lu-PSMA small molecule [ Time Frame: From Cycle 1 Day 1 up to 12 weeks after Cycle 1 Day 1 (each cycle is 8 weeks). ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brooklyn Methodist Hospital - New York PresbyterianBrooklynNew York11215
Lina Flores, RN
[email protected]
646-923-5883
David Nanus, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medicine New York PresbyterianNew YorkNew York10065
GUONC Research Team
[email protected]
Joseph Osborne, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Brooklyn, NY

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Brooklyn Methodist Hospital - New York Presbyterian· Brooklyn, NYWeill Cornell Medicine New York Presbyterian· New York, NY

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