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Clinical Trial · NCT05413850
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
Overview
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, LTDPhase
Phase 1/2
Contacts
Blue Earth Therapeutics
contact@blueearthtx.com
+44 (0)1865 634500
ClinicalTrials.gov
NCT05413850Drug / Compound
Lutetium (177Lu) rhPSMA-10.1
Isotope(s):
LUTETIUM-177
Radioisotope: Lu-177
Theranostic Role: Therapeutic Agent & SPECT Imaging
T1/2 (Half-Life): 6.7 Days
Decay Mode: BETA, GAMMA
Energy: Eβeta max 497 keV, Gamma 113-208 keV
Range: In Tissue: 0.25-2mm
Decay Daughters: Hf177
Status: FDA Approvals: PLUVICTO® (2022), LUTATHERA® (2017)
Target(s):
- PSMA
Eligibility
Inclusion
- Positive disease expression of PSMA as confirmed on PSMA PET/CT scan.
- Histologically confirmed adenocarcinoma of the prostate.
- Serum testosterone levels <50 ng/dL (1.73 nmol/L) after surgical or continued chemical castration.
- 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
- Diffuse marrow infiltration of disease (‘superscan’ appearance on full body 99mTc bone scan).
- Presence of PSMA-negative disease
- Known history of central nervous system (CNS) metastases.
- Known hypersensitivity to the therapeutic IMP, PSMA PET/CT tracer, or diagnostic IMP or any of its constituents
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