Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection

Part of paid clinical trials in Miami, Florida.

Sponsor
Blue Earth Therapeutics Ltd
Study ID
NCT05413850
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Lutetium (177Lu) rhPSMA-10.1 Injection — DRUG
    Therapeutic cycles of 177Lu-rhPSMA-10.1
  • 18F-rhPSMA-7.3 injection (in phase 1 only) — DIAGNOSTIC_TEST
    18F-rhPSMA-7.3 (in phase 1 only) at an administered activity of 296 MBq (8 mCi) for PET/CT scan to ascertain whether the subject has PSMA-positive disease.

Study Details

To determine the dose, safety, radiation dosimetry and efficacy of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.

Key Dates

Start date
Jul 20, 2022
Status verified
May 2026
Primary completion
Aug 27, 2026
Completion
Mar 31, 2028

Study Design

Enrollment
82 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1, Cohort A
    Subjects with PSMA positive disease will receive 5.55GBq of 177Lu-rhPSMA-10.1 (maximum of 3 cycles).
  • Experimental: Phase 1, Cohort B
    Subjects with PSMA positive disease will receive 7.4GBq of 177Lu-rhPSMA-10.1 (maximum of 3 cycles).
  • Experimental: Phase 2, Cohort 2A
    Subjects with PSMA positive disease will receive 2 doses at 10.00 GBq (270 mCi) followed by up to 5 additional doses at 7.40 GBq (200 mCi), all doses administered at 6-weekly intervals.
  • Experimental: Phase 2, Cohort 2B
    Subjects with PSMA positive disease will receive up to 8 doses at 7.40 GBq (200 mCi). The first 3 doses will be administered at 3-weekly intervals, with the remaining doses being administered at 6-weekly intervals.
  • Experimental: Phase 2, Cohort 2C (optional)
    If opened, subjects with PSMA positive disease will receive 2 doses at 14.80 GBq (400 mCi) followed by up to 4 additional doses at 7.40 GBq (200 mCi), all doses administered at 6-weekly intervals.

Primary Outcome Measure

Phase 1 Incidence of DLTs [ Time Frame: 6 weeks post final IMP ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Biogenix Molecular LLCMiamiFlorida33165
Jerry Joseph
[email protected]
786-791-1799
Cesar Santana, MD (PRINCIPAL_INVESTIGATOR)
NovaCure HealthMiamiFlorida33176
Anibal Munguia Midence
[email protected]
786-485-0770
Serguei Castaneda, MD (PRINCIPAL_INVESTIGATOR)
Emory University HospitalAtlantaGeorgia30322
David Michael Schuster
[email protected]
404-778-5625
Nashwa Jarkas
[email protected]
404-727-2193
David Michael Schuster, MD (PRINCIPAL_INVESTIGATOR)
XCancer Omaha / Urology Cancer CenterOmahaNebraska68130
Nordquist
[email protected]
(402) 991-8468
Luke Nordquist, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medicine - New York - Presbyterian HospitalNew YorkNew York10065-

Find similar trials in Miami, FL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Biogenix Molecular LLC· Miami, FLNovaCure Health· Miami, FLEmory University Hospital· Atlanta, GAXCancer Omaha / Urology Cancer Center· Omaha, NEWeill Cornell Medicine - New York - Presbyterian Hospital· New York, NY

Related Studies