XCancer
Blue Earth Therapeutics, LTD

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, LTD

Phase:

Phase 1/2

Contacts:

Blue Earth Therapeutics

contact@blueearthtx.com

+44 (0)1865 634500

Government Study Link:

NCT05413850 - Click here to see study on

ClinicalTrials.gov

Lutetium (177Lu) rhPSMA-10.1

Isotope(s):
Target(s):
  • PSMA
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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