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An Open-label, Multicentre, Integrated Phase 1 & 2 Study to Evaluate the Safety, Tolerability, Radiation Dosimetry and Anti-tumour Activity of Lutetium (177Lu) rhPSMA-10.1 Injection in Men With Metastatic Castrate-resistant Prostate Cancer
Description:
Part 2: to determine the efficacy, safety and radiation dosimetry of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.
Sponsor:
Blue Earth Therapeutics, LTDContacts:
Blue Earth Therapeuticscontact@blueearthtx.com
+44 (0)1865 634500
Government Study Link:
NCT05413850 - Click here to see study onClinicalTrials.gov
Lutetium (177Lu) rhPSMA-10.1
Isotope(s):
Target(s):
- PSMA
Inclusion
- Serum testosterone levels <50 ng/dL (1.73 nmol/L) after surgical or continued chemical castration.
- Histologically confirmed adenocarcinoma of the prostate.
- Positive disease expression of PSMA as confirmed on PSMA PET/CT scan.
- Have experienced disease progression on or after at least 1 NAAD, but have not received previous taxane chemo for mCRPC
- Presence of disease target or non-target lesions (per RECIST v1.1) on CT/MRI and/or Presence of disease on bone scan
Exclusion
- Known history of central nervous system (CNS) metastases.
- Presence of PSMA-negative disease
- Diffuse marrow infiltration of disease (‘superscan’ appearance on full body 99mTc bone scan).
- Known hypersensitivity to the therapeutic IMP, PSMA PET/CT tracer, or diagnostic IMP or any of its constituents
Patient Education
Patient Education Not Yet Provided
Publications
Publications Not Yet Provided
Locations
United States 🇺🇸
XCancer - Omaha
17607 Gold Plaza, Omaha, Nebraska 68130, United States
Washington University School of Medicine
St. Louis, Missouri, United States
Principal Investigator
Hyun Kim, MD
Biogenix Molecular LLC
Miami, Florida 33165, United States
Emory University
Atlanta, Georgia, United States
Netherlands 🇳🇱
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands
Principal Investigator
Dr. Nagarajah
