Status:
RECRUITING
Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection
Lead Sponsor:
Blue Earth Therapeutics Ltd
Collaborating Sponsors:
PSI CRO
Conditions:
Prostate Cancer
Metastatic Castration-resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
To determine the dose, safety, radiation dosimetry and efficacy of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Male subjects, 18 years of age or older with histologically confirmed adenocarcinoma of the prostate.
- Serum testosterone levels \<50 ng/dL (1.73 nmol/L) after surgical or continued chemical castration.
- 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.
- Positive disease expression of PSMA as confirmed on PSMA PET/CT scan.
- 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).
- 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).
- Prior major surgery must be at least 12 weeks prior to study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 with a life expectancy ≥6 months.
- Adequate bone marrow reserve and organ function as demonstrated by blood count, and serum biochemistry at baseline.
- Adequate contraception for patients and their partners.
- For Phase 1 mCRPC only: Subjects who have experienced disease progression on or after at least 1 NAAD (e.g. abiraterone, enzalutamide) and at least 1 course (but no more than 2 courses) of taxane-based chemotherapy. For Phase 2 mCRPC only: Subjects who have experienced disease progression on or after at least 1 NAAD (e.g. abiraterone, enzalutamide, apalutamide, darolutamide), but have not received previous taxane-based chemotherapy for the treatment of mCRPC.
Exclusion
- Known hypersensitivity to the therapeutic or diagnostic IMP or any of its constituents.
- Presence of significant PSMA-negative disease on ceCT/MRI scan
- Diffuse marrow infiltration of disease ('superscan' appearance on full body 99mTc bone scan).
- Symptomatic spinal cord compression, or clinical or radiological findings that are indicative of impending spinal cord compression.
- Known history of haematological malignancy.
- Known history of central nervous system (CNS) metastases.
- Histological findings consistent with neuroendocrine phenotype of prostate cancer.
- Known history of other solid malignancy that may reduce life expectancy and/or may interfere with disease assessment.
- Unresolved urinary tract obstruction defined as radiographic evidence of hydronephrosis with or without ureteric stent/nephrostomy.
- Any uncontrolled significant medical, psychiatric, or surgical condition or laboratory finding that would pose a risk to subject safety or interfere with study participation or interpretation of individual subject results.
- Ongoing treatment with bisphosphonates for bone-targeted therapy.
- Severe urinary incontinence that would preclude safe disposal of radioactive urine.
- Single kidney or renal transplant or any concomitant nephrotoxic therapy that might put the subject at high risk of renal toxicity during the study in the judgement of the investigator.
- Clinically significant abnormalities on a single 12 lead electrocardiogram (ECG) at screening.
- Previously received external beam irradiation to a field that includes more than 30% of the bone marrow or kidneys.
- Previous treatment with any of the following: PSMA targeted radionuclide therapy, Strontium-89, Samarium-153, Rhenium 186, Rhenium-188, Radium-223, hemi-body irradiation.
- Subjects with bilateral hip replacements or any significant metallic implants or objects, that may affect image quality and/or dosimetry calculations.
- Transfusion of blood products for the sole purpose of meeting the eligibility criteria for this clinical study.
- Participation in other studies involving IMP(s) within 28 days or 5 half-lives (whichever is longer) prior to study entry and/or during study participation.
Key Trial Info
Start Date :
July 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT05413850
Start Date
July 20 2022
End Date
March 31 2028
Last Update
September 23 2025
Active Locations (5)
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1
Biogenix Molecular LLC
Miami, Florida, United States, 33165
2
Washington University School of Medicine
St Louis, Missouri, United States, 63110
3
XCancer Omaha / Urology Cancer Center
Omaha, Nebraska, United States, 68130
4
Weill Cornell Medicine - New York - Presbyterian Hospital
New York, New York, United States, 10065