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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05413850
Recruitment Status : Recruiting
First Posted : June 10, 2022
Last Update Posted : February 3, 2023
Sponsor:
Collaborator:
PSI CRO
Information provided by (Responsible Party):
Blue Earth Therapeutics Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Metastatic Castration-resistant Prostate Cancer mCRPC Urogenital Neoplasms Prostatic Neoplasms Prostatic Diseases Drug: 177Lu-rhPSMA-10.1 injection Diagnostic Test: 18F-rhPSMA-7.3 injection Phase 1 Phase 2

Detailed Description:
This is an interventional, non-randomised, open-label, integrated Phase 1 & 2 study to assess the safety, radiation dosing regimen and anti-tumour activity of Lutetium (177Lu) rhPSMA-10.1 (Tx IMP) in men with metastatic castrate-resistant prostate cancer (mCRPC). The study will consist of 2 parts: a Phase 1, with safety, dose-finding, and dosimetry components, and a Phase 2, with assessment of efficacy and safety utilising the dose selected from Phase 1. Both phases will include subjects with prostate-specific membrane antigen (PSMA)-positive mCRPC as detected using 18F-rhPSMA-7.3 diagnostic IMP.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 20, 2022
Estimated Primary Completion Date : August 27, 2026
Estimated Study Completion Date : October 27, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 1, Cohort A
Subjects with PSMA positive disease will receive 5.55GBq of 177Lu-rhPSMA-10.1 (maximum of 3 cycles).
 Drug: 177Lu-rhPSMA-10.1 injection
Therapeutic cycles of 177Lu-rhPSMA-10.1
Other Name: 177Lu-rhPSMA-10.1

Diagnostic Test: 18F-rhPSMA-7.3 injection
18F-rhPSMA-7.3 at an administered activity of 296 MBq (8 mCi) for PET/CT scan to ascertain whether the subject has PSMA-positive disease.
Other Name: 18F-rhPSMA-7.3
Experimental: Phase 1, Cohort B
Subjects with PSMA positive disease will receive 7.4GBq of 177Lu-rhPSMA-10.1 (maximum of 2 cycles).
 Drug: 177Lu-rhPSMA-10.1 injection
Therapeutic cycles of 177Lu-rhPSMA-10.1
Other Name: 177Lu-rhPSMA-10.1

Diagnostic Test: 18F-rhPSMA-7.3 injection
18F-rhPSMA-7.3 at an administered activity of 296 MBq (8 mCi) for PET/CT scan to ascertain whether the subject has PSMA-positive disease.
Other Name: 18F-rhPSMA-7.3
Experimental: Phase 2, Cohort 1, post-chemotherapy mCRPC
Subjects with PSMA positive disease will receive up to 6 cycles of the Therapeutic IMP at the Recommended Phase 2 dose [RP2D]
 Drug: 177Lu-rhPSMA-10.1 injection
Therapeutic cycles of 177Lu-rhPSMA-10.1
Other Name: 177Lu-rhPSMA-10.1

Diagnostic Test: 18F-rhPSMA-7.3 injection
18F-rhPSMA-7.3 at an administered activity of 296 MBq (8 mCi) for PET/CT scan to ascertain whether the subject has PSMA-positive disease.
Other Name: 18F-rhPSMA-7.3
Experimental: Phase 2, Cohort 2, Taxane-naïve mCRPC
Subjects with PSMA positive disease will receive up to 6 cycles of the Therapeutic IMP at the Recommended Phase 2 dose [RP2D] .
 Drug: 177Lu-rhPSMA-10.1 injection
Therapeutic cycles of 177Lu-rhPSMA-10.1
Other Name: 177Lu-rhPSMA-10.1

Diagnostic Test: 18F-rhPSMA-7.3 injection
18F-rhPSMA-7.3 at an administered activity of 296 MBq (8 mCi) for PET/CT scan to ascertain whether the subject has PSMA-positive disease.
Other Name: 18F-rhPSMA-7.3


Outcome Measures
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Primary Outcome Measures :
  1. Phase 1 Incidence of DLTs [ Time Frame: 6 weeks post final IMP ]
    Incidence of DLTs during the DLT observation period.

  2. Phase 1 Frequency and nature of TEAEs [ Time Frame: End of study ]
    Frequency and nature of treatment-emergent adverse events (TEAEs).

  3. Phase 2, anti-tumour response [ Time Frame: 12 weekly intervals ]
    The number of subjects with an anti-tumour response defined as ≥50% reduction in PSA level from baseline.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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

Exclusion Criteria:

  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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05413850


Contacts
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Contact: Blue Earth Therapeutics +44 (0)1865 634500 contact@blueearthTx.com

Locations
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United States, Maryland
Advanced Molecular Imaging and Therapy Recruiting
Glen Burnie, Maryland, United States, 21061
Contact: Morris         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Baumann         
United States, Nebraska
XCancer Omaha / Urology Cancer Center Recruiting
Omaha, Nebraska, United States, 68130
Contact: Nordquist         
United States, New York
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Ghesani         
Sponsors and Collaborators
Blue Earth Therapeutics Ltd
PSI CRO
Investigators
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Study Director: Blue Earth Therapeutics Blue Earth Therapeutics
More Information
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Additional Information:

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Responsible Party: Blue Earth Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT05413850    
Other Study ID Numbers: BET-PSMA-121
First Posted: June 10, 2022    Key Record Dates
Last Update Posted: February 3, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Blue Earth Therapeutics Ltd:
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:
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Prostatic Neoplasms
Neoplasms
Urogenital Neoplasms
Prostatic Diseases
Genital Neoplasms, Male
Neoplasms by Site
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Male Urogenital Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications