Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
82 participants
INTERVENTIONAL
2022-07-20
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1, Cohort A
Subjects with PSMA positive disease will receive 5.55GBq of 177Lu-rhPSMA-10.1 (maximum of 3 cycles).
Lutetium (177Lu) rhPSMA-10.1 Injection
Therapeutic cycles of 177Lu-rhPSMA-10.1
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.
Phase 1, Cohort B
Subjects with PSMA positive disease will receive 7.4GBq of 177Lu-rhPSMA-10.1 (maximum of 3 cycles).
Lutetium (177Lu) rhPSMA-10.1 Injection
Therapeutic cycles of 177Lu-rhPSMA-10.1
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.
Phase 2, Cohort 2A
Subjects with PSMA positive disease will receive 2 doses at 10.00 GBq (270 mCi) followed by up to 5 additional doses at 7.40 GBq (200 mCi), all doses administered at 6-weekly intervals.
Lutetium (177Lu) rhPSMA-10.1 Injection
Therapeutic cycles of 177Lu-rhPSMA-10.1
Phase 2, Cohort 2B
Subjects with PSMA positive disease will receive up to 8 doses at 7.40 GBq (200 mCi). The first 3 doses will be administered at 3-weekly intervals, with the remaining doses being administered at 6-weekly intervals.
Lutetium (177Lu) rhPSMA-10.1 Injection
Therapeutic cycles of 177Lu-rhPSMA-10.1
Phase 2, Cohort 2C (optional)
If opened, subjects with PSMA positive disease will receive 2 doses at 14.80 GBq (400 mCi) followed by up to 4 additional doses at 7.40 GBq (200 mCi), all doses administered at 6-weekly intervals.
Lutetium (177Lu) rhPSMA-10.1 Injection
Therapeutic cycles of 177Lu-rhPSMA-10.1
Interventions
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Lutetium (177Lu) rhPSMA-10.1 Injection
Therapeutic cycles of 177Lu-rhPSMA-10.1
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 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. 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 Criteria
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.
18. Transfusion of blood products for the sole purpose of meeting the eligibility criteria for this clinical study.
19. 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.
18 Years
MALE
No
Sponsors
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PSI CRO
INDUSTRY
Blue Earth Therapeutics Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Blue Earth Therapeutics
Role: STUDY_DIRECTOR
Blue Earth Therapeutics
Locations
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Biogenix Molecular LLC
Miami, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
XCancer Omaha / Urology Cancer Center
Omaha, Nebraska, United States
Weill Cornell Medicine - New York - Presbyterian Hospital
New York, New York, United States
Jules Bordet Institute
Brussels, , Belgium
Saint Luc University Hospital
Brussels, , Belgium
University Hospital Ghent
Ghent, , Belgium
University Hospital Center Sart-Tilman
Liège, , Belgium
Radboud UMC
Nijmegen, Gelderland, Netherlands
Bristol Hematology and Oncology Center
Bristol, , United Kingdom
Beatson West of Scotland Cancer Center
Glasgow, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Dierks A, Gable A, Rinscheid A, Wienand G, Pfob CH, Kircher M, Enke JS, Janzen T, Patt M, Trepel M, Weckermann D, Bundschuh RA, Lapa C. First Safety and Efficacy Data with the Radiohybrid 177Lu-rhPSMA-10.1 for the Treatment of Metastatic Prostate Cancer. J Nucl Med. 2024 Mar 1;65(3):432-437. doi: 10.2967/jnumed.123.266741.
Related Links
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Sponsor website
Other Identifiers
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BET-PSMA-121
Identifier Type: -
Identifier Source: org_study_id
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