NCT05413850 · Blue Earth Therapeutics Ltd
Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection
What this study is about
To determine the dose, safety, radiation dosimetry and effectiveness of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.
View original scientific description
To determine the dose, safety, radiation dosimetry and efficacy of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.
Interventions
DRUG
Lutetium (177Lu) rhPSMA-10.1 Injection
Therapeutic cycles of 177Lu-rhPSMA-10.1
DIAGNOSTIC_TEST
18F-rhPSMA-7.3 injection (in phase 1 only)
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.
Primary outcome measures
Phase 1 Incidence of DLTs
Time frame: 6 weeks post final IMP
Incidence of DLTs during the DLT observation period.
Phase 1 Frequency and nature of TEAEs
Time frame: End of study
Frequency and nature of treatment-emergent adverse events (TEAEs).
Phase 2 Evaluate the efficacy of Lutetium (177Lu) rhPSMA-10.1 Injection
Time frame: 6 weekly intervals
The number of subjects with an anti-tumour response defined as ≥50% reduction in PSA level from baseline to the end of treatment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 initiation of study treatment (except for Luteinising Hormone-releasing Hormone or GnRH). 6. Resolution of all previous treatment related toxicities to CTCAE version 5.0 grade of ≤1 (except for chemotherapy induced alopecia and grade 2 peripheral neuropathy or grade 2 urinary frequency which are allowed). 7. Prior major surgery must be at least 12 weeks prior to study entry. 8. Eastern Cooperativ
Where
- Miami, Florida
- Atlanta, Georgia
- Omaha, Nebraska
- New York, New York
Collaborators
PSI CRO
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2026 · Source of record for eligibility and locations