RECRUITING

Anti-tumour Activity of (177Lu) RhPSMA-10.1 Injection

Conditions

Prostate Cancer Metastatic Castration-resistant Prostate Cancer MCRPC Urogenital Neoplasms Prostatic Neoplasms Prostatic Diseases PSMA 177Lu rhPSMA-10.1 18F-rhPSMA-7.3 BET-PSMA-121 Blue Earth Therapeutics Limited Radiohybrid Radiopharmaceuticals

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-10-31

Study Completion:2026-10-27

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05413850

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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 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 Cooperative Oncology Group (ECOG) performance status of 0-2 with a life expectancy ≥6 months. 9. Adequate bone marrow reserve and organ function as demonstrated by blood count, and serum biochemistry at baseline. 10. Adequate contraception for patients and their partners. 11. Cohorts: 1. Phase 1 and Phase 2 post-chemotherapy mCRPC 2. Phase 2 taxane-naïve mCRPC	1. Known hypersensitivity to the therapeutic or diagnostic IMP or any of its constituents. 2. Presence of significant PSMA-negative disease on ceCT/MRI scan 3. Diffuse marrow infiltration of disease ('superscan' appearance on full body 99mTc bone scan). 4. Symptomatic spinal cord compression, or clinical or radiological findings that are indicative of impending spinal cord compression. 5. Known history of haematological malignancy. 6. Known history of central nervous system (CNS) metastases. 7. Histological findings consistent with neuroendocrine phenotype of prostate cancer. 8. Known history of other solid malignancy that may reduce life expectancy and/or may interfere with disease assessment. 9. Unresolved urinary tract obstruction defined as radiographic evidence of hydronephrosis with or without ureteric stent/nephrostomy. 10. 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. 11. Ongoing treatment with bisphosphonates for bone-targeted therapy. 12. Severe urinary incontinence that would preclude safe disposal of radioactive urine. 13. 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. 14. Clinically significant abnormalities on a single 12 lead electrocardiogram (ECG) at screening. 15. Previously received external beam irradiation to a field that includes more than 30% of the bone marrow or kidneys. 16. Previous treatment with any of the following: PSMA targeted radionuclide therapy, Strontium-89, Samarium-153, Rhenium 186, Rhenium-188, Radium-223, hemi-body irradiation. 17. Subjects with bilateral hip replacements or any significant metallic implants or objects, that may affect image quality and/or dosimetry calculations.

Inclusion Criteria

Exclusion Criteria

1. 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 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 Cooperative Oncology Group (ECOG) performance status of 0-2 with a life expectancy ≥6 months.
9. Adequate bone marrow reserve and organ function as demonstrated by blood count, and serum biochemistry at baseline.
10. Adequate contraception for patients and their partners.
11. Cohorts:
1. Phase 1 and Phase 2 post-chemotherapy mCRPC
2. Phase 2 taxane-naïve mCRPC

1. Known hypersensitivity to the therapeutic or diagnostic IMP or any of its constituents.
2. Presence of significant PSMA-negative disease on ceCT/MRI scan
3. Diffuse marrow infiltration of disease ('superscan' appearance on full body 99mTc bone scan).
4. Symptomatic spinal cord compression, or clinical or radiological findings that are indicative of impending spinal cord compression.
5. Known history of haematological malignancy.
6. Known history of central nervous system (CNS) metastases.
7. Histological findings consistent with neuroendocrine phenotype of prostate cancer.
8. Known history of other solid malignancy that may reduce life expectancy and/or may interfere with disease assessment.
9. Unresolved urinary tract obstruction defined as radiographic evidence of hydronephrosis with or without ureteric stent/nephrostomy.
10. 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.
11. Ongoing treatment with bisphosphonates for bone-targeted therapy.
12. Severe urinary incontinence that would preclude safe disposal of radioactive urine.
13. 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.
14. Clinically significant abnormalities on a single 12 lead electrocardiogram (ECG) at screening.
15. Previously received external beam irradiation to a field that includes more than 30% of the bone marrow or kidneys.
16. Previous treatment with any of the following: PSMA targeted radionuclide therapy, Strontium-89, Samarium-153, Rhenium 186, Rhenium-188, Radium-223, hemi-body irradiation.
17. Subjects with bilateral hip replacements or any significant metallic implants or objects, that may affect image quality and/or dosimetry calculations.

Contacts and Locations

Study Contact

Blue Earth Therapeutics

CONTACT

+44 (0)1865 634500

contact@blueearthTx.com

Principal Investigator

Blue Earth Therapeutics

STUDY_DIRECTOR

Blue Earth Therapeutics

Study Locations (Sites)

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

XCancer Omaha / Urology Cancer Center

Omaha, Nebraska, 68130

United States

Mount Sinai Medical Center

New York, New York, 10029

United States

Weill Cornell Medicine - New York - Presbyterian Hospital

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Blue Earth Therapeutics Ltd

Blue Earth Therapeutics, STUDY_DIRECTOR, Blue Earth Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-31

Study Completion Date2026-10-27

Study Record Updates

Study Start Date2024-10-31

Study Completion Date2026-10-27

Terms related to this study

Keywords Provided by Researchers

PSMA
mCRPC
Prostate cancer
177Lu rhPSMA-10.1
18F-rhPSMA-7.3
BET-PSMA-121
Blue Earth Therapeutics Limited
Radiohybrid
Radiopharmaceuticals

Additional Relevant MeSH Terms

Prostate Cancer
Metastatic Castration-resistant Prostate Cancer
MCRPC
Urogenital Neoplasms
Prostatic Neoplasms
Prostatic Diseases