Blue Earth Therapeutics Ltd
To determine the dose, safety, radiation dosimetry and efficacy of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.
This is an interventional, open-label, integrated Phase 1 \& 2 study to assess the safety, tolerability, radiation dosing regimen and anti-tumour activity of Lutetium (177Lu) rhPSMA-10.1 (IMP) in men with metastatic castrate-resistant prostate cancer (mCRPC). The study will consist of 2 parts: a non-randomised Phase 1 part, with safety, dose-finding, and dosimetry components, and a randomised Phase 2 part, with efficacy and safety assessments, and testing dosing regimens selected following analysis of the safety and dosimetry data in Phase 1. Both phases will include subjects with prostate-spe…
Inclusion Criteria: 1. Male subjects, 18 years of age or older with histologically confirmed adenocarcinoma of the prostate. 2. Serum testosterone levels \<50 ng/dL (1.73 nmol/L) after surgical or continued chemical castration. 3. Presence of disease target or non target lesions (per RECIST v1.1) on CT/MRI and/or presence of disease on full body 99mTc bone scan performed within 28 days of screening. 4. Positive disease expression of PSMA as confirmed on PSMA PET/CT scan. 5. At least 4 weeks or 5 half-lives (whichever is longer) elapsed between last anti-cancer treatment administration and the…
Therapeutic cycles of 177Lu-rhPSMA-10.1
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.