First Safety and Efficacy Data with the Radiohybrid 177Lu-rhPSMA-10.1 for the Treatment of Metastatic Prostate Cancer.
Alexander Dierks, Alexander Gäble, Andreas Rinscheid...
https://pubmed.ncbi.nlm.nih.gov/38164586Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
MALE
ID05413850
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
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 PET/CT 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
Age: 18Years +
MALE
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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to approximately 36 weeks depending on number and timing of doses
Participants receive therapeutic cycles of Lutetium (177Lu) rhPSMA-10.1 Injection at varying doses depending on cohort assignment, with dosing intervals ranging from 3 to 6 weeks.
Multiple visits at 3- or 6-week intervals depending on cohort, up to 8 dosing visits
Follow-up
Duration - At least 6 weeks post final dose
Participants are monitored for safety and treatment effects after the final dose.
1 or more visits post-treatment for safety assessments
Trial Site Locations
Total: 21 locations
1
Biogenix Molecular LLC
Miami, Florida, United States, 33165
Actively Recruiting
2
NovaCure Health
Miami, Florida, United States, 33176
Actively Recruiting
3
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
XCancer Omaha / Urology Cancer Center
Omaha, Nebraska, United States, 68130
Actively Recruiting
5
Weill Cornell Medicine - New York - Presbyterian Hospital
New York, New York, United States, 10065
Completed
6
Saint Luc University Hospital
Brussels, Belgium, 1200
Actively Recruiting
7
University Hospital Ghent
Ghent, Belgium, 9000
Actively Recruiting
8
University Hospital Leuven
Leuven, Belgium
Actively Recruiting
9
University Hospital Aachen
Aachen, Germany
Actively Recruiting
10
Universitätsklinikum Augsburg
Augsburg, Germany
Actively Recruiting
11
University Hospital Essen
Essen, Germany
Actively Recruiting
12
Hospital Rechts der Isar
Munich, Germany
Actively Recruiting
13
Radboud UMC
Nijmegen, Gelderland, Netherlands, 6525GA
Actively Recruiting
14
Meander Medisch Centrum
Amersfoort, Netherlands
Actively Recruiting
15
Bristol Hematology and Oncology Center
Bristol, United Kingdom, BS2 8ED
Actively Recruiting
16
Beatson West of Scotland Cancer Center
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
17
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Actively Recruiting
18
James Cook University Hospital
Middlesbrough, United Kingdom, TS4 3BW
Actively Recruiting
19
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
Actively Recruiting
20
Weston Park
Sheffield, United Kingdom
Actively Recruiting
21
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
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Research Team
B
Blue Earth Therapeutics
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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