Actively Recruiting
Study of Lutetium 177Lu rhPSMA-10.1 Injection to Treat Men With Metastatic Castrate-Resistant Prostate Cancer Phase 1 and 2 Testing Safety, Dosage, and Effectiveness
Led by Blue Earth Therapeutics Ltd · Updated on 2026-05-14
82
Participants Needed
21
Research Sites
83 weeks
Total Duration
On this page
Sponsors
B
Blue Earth Therapeutics Ltd
Lead Sponsor
P
PSI CRO
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying Lutetium 177Lu rhPSMA-10.1 in men with metastatic castrate-resistant prostate cancer mCRPC that expresses prostate-specific membrane antigen PSMA. This open-label Phase 1 and 2 study aims to determine the appropriate dose, safety, radiation exposure, and anti-tumor activity of this treatment. Participants include men whose cancer has progressed despite prior therapies, with Phase 1 focusing on those who had chemotherapy and Phase 2 on those who have not received taxane chemotherapy. Participants will receive different dosing regimens of 177Lu-rhPSMA-10.1 based on their study group. Doses vary from 5.55GBq to 14.80GBq, administered in up to 8 cycles at intervals of 3 to 6 weeks. Phase 1 includes dose-finding, safety, and radiation dosimetry assessments, while Phase 2 evaluates efficacy and safety of the dosing schedules chosen from Phase 1. A PETCT scan using 18F-rhPSMA-7.3 is used in Phase 1 to confirm PSMA-positive disease. During the study, participants will undergo regular monitoring including imaging scans, blood tests, and assessments of treatment side effects. Researchers will track dose-limiting toxicities, treatment-emergent adverse events, and efficacy measured at six-week intervals. Participants will be observed up to six weeks after their final dose for safety. The study duration and follow-up depend on treatment cycles and individual response, with ongoing evaluation of radiation dosage and anti-tumor effects.
CONDITIONS
Brief Title
Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subjects, 18 years of age or older with histologically confirmed adenocarcinoma of the prostate.
- Serum testosterone levels below 50 ng/dL (1.73 nmol/L) after surgical or continued chemical castration.
- Presence of disease target or non-target lesions on CT/MRI or full body 99mTc bone scan within 28 days of screening.
- Positive PSMA expression confirmed on PSMA PET/CT scan.
- At least 4 weeks or 5 half-lives (whichever is longer) since last anti-cancer treatment before starting study treatment, except for Luteinising Hormone-releasing Hormone or GnRH.
- Resolution of previous treatment toxicities to grade 1 or less except for chemotherapy-induced alopecia and grade 2 peripheral neuropathy or urinary frequency.
- Prior major surgery at least 12 weeks before study entry.
- ECOG performance status 0-2 with life expectancy of at least 6 months.
- Adequate bone marrow reserve and organ function at baseline.
- Adequate contraception for patients and their partners.
- For Phase 1: disease progression after at least 1 novel androgen axis drug and 1 to 2 courses of taxane chemotherapy.
- For Phase 2: disease progression after at least 1 novel androgen axis drug but no prior taxane chemotherapy for mCRPC.
You will not qualify if you...
- Known hypersensitivity to the therapeutic or diagnostic agent or any of its components.
- Presence of significant PSMA-negative disease on contrast-enhanced CT/MRI.
- Diffuse marrow infiltration of disease as seen on full body 99mTc bone scan.
- Symptomatic or impending spinal cord compression.
- History of hematological malignancy or central nervous system metastases.
- Neuroendocrine phenotype of prostate cancer confirmed by histology.
- History of other solid malignancies affecting life expectancy or disease assessment.
- Unresolved urinary tract obstruction.
- Uncontrolled significant medical, psychiatric, or surgical conditions or abnormal lab findings posing safety risks or interfering with participation.
- Ongoing bisphosphonate treatment for bone-targeted therapy.
- Severe urinary incontinence preventing safe disposal of radioactive urine.
- Single kidney, renal transplant, or use of nephrotoxic therapy posing high renal toxicity risk.
- Clinically significant ECG abnormalities at screening.
- Prior external beam irradiation involving over 30% of bone marrow or kidneys.
- Previous PSMA-targeted radionuclide therapy or similar treatments.
- Bilateral hip replacements or significant metallic implants affecting imaging quality.
- Blood transfusions solely to meet eligibility.
- Participation in other investigational medicinal product studies within 28 days or 5 half-lives before or during this study.
- History of clinically significant lung disease.
- Prior thoracic external beam radiotherapy.
- Abnormal PSMA PET uptake in lung above expected physiological levels.
Research Team
B
Blue Earth Therapeutics
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