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

May 12, 2026 updated by: Blue Earth Therapeutics Ltd

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 with metastatic castrate-resistant prostate cancer (mCRPC). The study will consist of 2 parts: a non-randomised Phase 1 part, with safety, dose-finding, and dosimetry components, and a randomised Phase 2 part, with efficacy and safety assessments, and testing dosing regimens selected following analysis of the safety and dosimetry data in Phase 1. Both phases will include subjects with prostate-specific membrane antigen (PSMA)-positive mCRPC, which has progressed following prior therapy. Phase 1 will include a post-chemotherapy mCRPC cohort of subjects who have experienced disease progression on or after at least 1 novel androgen axis drug (NAAD) (e.g. abiraterone, enzalutamide) and at least 1 course (but no more than 2 courses) of taxane-based chemotherapy. Phase 2 will include 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.

Study Type

Interventional

Enrollment (Estimated)

82

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
      • Ghent, Belgium, 9000
        • Recruiting
        • University Hospital Ghent
        • Contact:
      • Leuven, Belgium
  • Germany
      • Aachen, Germany
        • Recruiting
        • University Hospital Aachen
        • Contact:
      • Augsburg, Germany
      • Essen, Germany
      • Munich, Germany
        • Recruiting
        • Hospital Rechts der Isar
        • Contact:
  • Netherlands
      • Amersfoort, Netherlands
    • Gelderland
  • United Kingdom
      • Bristol, United Kingdom, BS2 8ED
        • Recruiting
        • Bristol Hematology and Oncology Center
        • Contact:
      • Glasgow, United Kingdom, G12 0YN
        • Recruiting
        • Beatson West of Scotland Cancer Center
        • Contact:
      • London, United Kingdom, EC1A 7BE
        • Recruiting
        • St Bartholomew'S Hospital
        • Contact:
      • Middlesbrough, United Kingdom, TS4 3BW
        • Recruiting
        • James Cook University Hospital
        • Contact:
      • Oxford, United Kingdom
        • Recruiting
        • Oxford University Hospitals NHS Foundation Trust
        • Contact:
      • Sheffield, United Kingdom
        • Recruiting
        • Weston Park
        • Contact:
          • Omar Din
          • Phone Number: +44 (0) 114226 5068
          • Email: o.din@nhs.net
      • Southampton, United Kingdom, SO16 6YD
        • Recruiting
        • University Hospital Southampton NHS Foundation Trust
        • Contact:
  • United States
    • Florida
      • Miami, Florida, United States, 33165
        • Recruiting
        • Biogenix Molecular LLC
        • Principal Investigator:
          • Cesar Santana, MD
        • Contact:
      • Miami, Florida, United States, 33176
        • Recruiting
        • NovaCure Health
        • Contact:
        • Principal Investigator:
          • Serguei Castaneda, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Michael Schuster, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • XCancer Omaha / Urology Cancer Center
        • Principal Investigator:
          • Luke Nordquist, MD
        • Contact:
    • New York
      • New York, New York, United States, 10065
        • Completed
        • Weill Cornell Medicine - New York - Presbyterian Hospital

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.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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/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:

  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.
  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.
  20. Any history of clinically significant parenchymal lung disease e.g. interstitial lung disease or bullous emphysema.
  21. Any history of prior thoracic external beam radiotherapy.
  22. Presence of abnormal PSMA PET uptake in the lung parenchyma above expected physiological levels, as determined by local assessment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Lutetium (177Lu) rhPSMA-10.1 Injection
Therapeutic cycles of 177Lu-rhPSMA-10.1
Other Names:
  • 177Lu-rhPSMA-10.1
Diagnostic test: 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 Names:
  • 18F-rhPSMA-7.3 (in phase 1 only)
Experimental: Phase 1, Cohort B
Subjects with PSMA positive disease will receive 7.4GBq of 177Lu-rhPSMA-10.1 (maximum of 3 cycles).
Drug: Lutetium (177Lu) rhPSMA-10.1 Injection
Therapeutic cycles of 177Lu-rhPSMA-10.1
Other Names:
  • 177Lu-rhPSMA-10.1
Diagnostic test: 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 Names:
  • 18F-rhPSMA-7.3 (in phase 1 only)
Experimental: 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.
Drug: Lutetium (177Lu) rhPSMA-10.1 Injection
Therapeutic cycles of 177Lu-rhPSMA-10.1
Other Names:
  • 177Lu-rhPSMA-10.1
Experimental: 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.
Drug: Lutetium (177Lu) rhPSMA-10.1 Injection
Therapeutic cycles of 177Lu-rhPSMA-10.1
Other Names:
  • 177Lu-rhPSMA-10.1
Experimental: 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.
Drug: Lutetium (177Lu) rhPSMA-10.1 Injection
Therapeutic cycles of 177Lu-rhPSMA-10.1
Other Names:
  • 177Lu-rhPSMA-10.1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1 Incidence of DLTs
Time Frame: 6 weeks post final IMP
Incidence of DLTs during the DLT observation period.
6 weeks post final IMP
Phase 1 Frequency and nature of TEAEs
Time Frame: End of study
Frequency and nature of treatment-emergent adverse events (TEAEs).
End of study
Phase 2 Evaluate the efficacy of Lutetium (177Lu) rhPSMA-10.1 Injection
Time Frame: 6 weekly intervals
The number of subjects with an anti-tumour response defined as ≥50% reduction in PSA level from baseline to the end of treatment.
6 weekly intervals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Blue Earth Therapeutics Ltd

Collaborators

PSI CRO

Investigators

  • Study Director: Blue Earth Therapeutics, Blue Earth Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start (Actual)

July 20, 2022

Primary Completion (Estimated)

August 27, 2026

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

May 20, 2022

First Submitted That Met QC Criteria

June 9, 2022

First Posted (Actual)

June 10, 2022

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BET-PSMA-121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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