Tests a radioactive drug in men with advanced prostate cancer

Trial details

Who runs it

Blue Earth Therapeutics Ltd

Trial code

NCT05413850EU 2024-511537-35-00

Record updated

14 May 2026

Original 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.Read full original descriptionShow less

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

To determine the dose, safety, radiation dosimetry and efficacy of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.

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: Ongoing treatment with bisphosphonates for bone-targeted therapy; 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; 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; 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; Any history of prior thoracic external beam radiotherapy; 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); 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; Any history of clinically significant parenchymal lung disease e.g. interstitial lung disease or bullous emphysema; 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; Symptomatic spinal cord compression, or clinical or radiological findings that are indicative of impending spinal cord compression; Unresolved urinary tract obstruction defined as radiographic evidence of hydronephrosis with or without ureteric stent/nephrostomy; Severe urinary incontinence that would preclude safe disposal of radioactive urine; Clinically significant abnormalities on a single 12 lead electrocardiogram (ECG) at screening; Transfusion of blood products for the sole purpose of meeting the eligibility criteria for this clinical study; Presence of abnormal PSMA PET uptake in the lung parenchyma above expected physiological levels, as determined by local assessment.

ClinicalTrials.gov NCT05413850 · EU CTIS 2024-511537-35-00