Study With [225Ac]Ac-FL-020 in mCRPC Participants

Part of paid clinical trials in Duarte, California.

Sponsor
Full-Life Technologies GmbH
Study ID
NCT06492122
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • [225Ac]Ac-FL-020 — DRUG
    \[225Ac\]Ac-FL-020 injected intravenously
  • Blood samples for PK — DRUG
    Following the first injection of \[225Ac\]Ac-FL-020, blood samples after treatment will be collected for PK evaluation.
  • [111In]In-FL-020 — DRUG
    A dose of \[111In\]In-FL-020 will be injected prior to the first dose of \[225Ac\]Ac-FL-020 for dosimetry evaluation
  • Blood and urine samples collection — PROCEDURE
    For dosimetry evaluation and urine excretion assessment, blood and urine samples will be collected after the injection of \[111In\]In-FL-020
  • SPECT/CT images — PROCEDURE
    For dosimetry evaluation, SPECT/CTs will be performed following the injection of \[111In\]In-FL-020.

Study Details

The purpose of this study is to evaluate the safety, therapeutic effect, and pharmacokinetics of \[225Ac\]Ac-FL-020 in participants with metastatic castration-resistant prostate cancer (mCRPC).

Key Dates

Start date
Aug 30, 2024
Status verified
May 2026
Primary completion
Oct 31, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: [225Ac]Ac-FL-020
    Treatment with \[225Ac\]Ac-FL-020 administered intravenously. 10 patients will also receive \[111In\]In-FL-020 for dosimetry purposes.

Primary Outcome Measure

Dose escalation: Incidence of Dose-Limiting Toxicities (DLTs). [ Time Frame: 28 days after the first injection of [225Ac]Ac-FL-020 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Jennifer Simpson
Jeffrey Wong, MD (PRINCIPAL_INVESTIGATOR)
Chao Family Comprehensive Cancer CenterIrvineCalifornia92612
Amanda Macaraeg
[email protected]
714-456-8000
Shyam Srinivas, MD (PRINCIPAL_INVESTIGATOR)
University of StanfordStanfordCalifornia94305
David G. Marcellus
Andrei Iagaru, MD (PRINCIPAL_INVESTIGATOR)
Hong Song, MD (PRINCIPAL_INVESTIGATOR)
University Hospital of ClevelandClevelandOhio44106
Cheryl L Eitman, Clinical research Nurse
[email protected]
+1 216 392-6512
Pedro Barata, MD (PRINCIPAL_INVESTIGATOR)
University of Virginia Cancer CenterCharlottesvilleVirginia22903
Robert Dreicer, Principal Investigator
[email protected]
+1 434-924-1775
Christine P Martin, Clinical Trial Coordinator
[email protected]

Find similar trials in Duarte, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
City of Hope Medical Center· Duarte, CAChao Family Comprehensive Cancer Center· Irvine, CAUniversity of Stanford· Stanford, CAUniversity Hospital of Cleveland· Cleveland, OHUniversity of Virginia Cancer Center· Charlottesville, VA

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