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Prostate CancerPhase 1/2NCT05413850

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

A Phase 1/2 study testing Lutetium (177Lu) rhPSMA-10.1 Injection and 18F-rhPSMA-7.3 injection (in phase 1 only) in people with Prostate Cancer and Metastatic Castration-resistant Prostate Cancer, run by Blue Earth Therapeutics Ltd at 21 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Lutetium (177Lu) rhPSMA-10.1 Injection and 18F-rhPSMA-7.3 injection (in phase 1 only)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
21 sitesin 5 countries
Study dates
20 Jul 2022to 31 Mar 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

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

Trial locations and contacts

21 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Blue Earth Therapeutics contact

+44 (0)1865 634500

contact@blueearthTx.com

21 sites in 5 countries

United Kingdom7 sites, 7 recruiting

  • Bristol Hematology and Oncology Center

    Bristol, BS2 8ED

    Amarnath Challapalli, MD, +44 (0) 117 923 0000, Amarnath.Challapalli@uhbw.nhs.uk

    Recruiting

  • Beatson West of Scotland Cancer Center

    Glasgow, G12 0YN

    David Colville, +44 (0) 141 301 7000, dave.colville@glasgow.ac.uk

    Recruiting

  • St Bartholomew's Hospital

    London, EC1A 7BE

    Kenrick Ng, MD, +44 (0)20 7377 700, kenrick.ng3@nhs.net

    Recruiting

  • James Cook University Hospital

    Middlesbrough, TS4 3BW

    Darren Leaning, MD, +44 (0) 164285 0850, d.leaning@nhs.net

    Recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford

    Philip Camilleri, +44 (0)1865 572033, philip.camilleri@ouh.nhs.uk

    Recruiting

  • Weston Park

    Sheffield

    Omar Din, +44 (0) 114226 5068, o.din@nhs.net

    Recruiting

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD

    Simon Crabb, MD, +44 (0) 2381 205 170, s.j.crabb@southampton.ac.uk

    Recruiting

Other trials in United Kingdom

United States5 sites, 4 recruiting

  • Emory University Hospital

    Atlanta, Georgia, 30322

    David Michael Schuster, 404-778-5625, dschust@emory.edu

    Nashwa Jarkas, 404-727-2193, njarkas@emory.edu

    Recruiting

  • Biogenix Molecular LLC

    Miami, Florida, 33165

    Jerry Joseph, 786-791-1799, jjoseph@cira-health.com

    Cesar Santana, MD

    Recruiting

  • NovaCure Health

    Miami, Florida, 33176

    Anibal Munguia Midence, 786-485-0770, amunguia@novacurehealth.com

    Serguei Castaneda, MD

    Recruiting

  • Weill Cornell Medicine - New York - Presbyterian Hospital

    New York, New York, 10065

    Completed

  • XCancer Omaha / Urology Cancer Center

    Omaha, Nebraska, 68130

    Nordquist, (402) 991-8468, drnordquist@gucancer.com

    Luke Nordquist, MD

    Recruiting

Other trials in United States

Germany4 sites, 4 recruiting

  • University Hospital Aachen

    Aachen

    Felix Mottaghy, +49 241 80-35905, fmottaghy@ukaachen.de

    Recruiting

  • Universitätsklinikum Augsburg

    Augsburg

    Constantin Lapa, 0821 400 -168952, constantin.lapa@uk-augsburg.de

    Recruiting

  • University Hospital Essen

    Essen

    Boris Hadaschik, boris.hadaschik@uk-essen.de

    Recruiting

  • Hospital Rechts der Isar

    Munich

    Matthias Eiber, +49 (89) 41404549, matthias.eiber@tum.de

    Recruiting

Other trials in Germany

Belgium3 sites, 3 recruiting

  • Saint Luc University Hospital

    Brussels, 1200

    Emmanuel Seront, +32 (2764) 51 06, emmanuel.seront@saintluc.uclouvain.be

    Recruiting

  • University Hospital Ghent

    Ghent, 9000

    Charles van Praet, +32 (9) 332 1955, charles.vanpraet@uzgent.be

    Recruiting

  • University Hospital Leuven

    Leuven

    Karolien Goffin, +32 16 34 37 15, karolien.goffin@uzleuven.be

    Recruiting

Other trials in Belgium

Netherlands2 sites, 2 recruiting

  • Meander Medisch Centrum

    Amersfoort

    Joyce van Dodewaard-de Jong, 033-850 7278, jm.van.dodewaard@meandermc.nl

    Recruiting

  • Radboud UMC

    Nijmegen, Gelderland, 6525GA

    Nagarajah, MD, james.nagarajah@radboudumc.nl

    Recruiting

Other trials in Netherlands

About this study

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

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 the 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.

Being tested
Lutetium (177Lu) rhPSMA-10.1 Injection, 18F-rhPSMA-7.3 injection (in phase 1 only)
Keywords
PSMA, mCRPC, Prostate cancer, 177Lu rhPSMA-10.1, 18F-rhPSMA-7.3, BET-PSMA-121, Blue Earth Therapeutics Limited, Radiohybrid, Radiopharmaceuticals
Medical subject headings
Prostatic Neoplasms, Urogenital Neoplasms, Prostatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lutetium (177Lu) rhPSMA-10.1 InjectionDrug

    Also called 177Lu-rhPSMA-10.1

    Therapeutic cycles of 177Lu-rhPSMA-10.1

  • 18F-rhPSMA-7.3 injection (in phase 1 only)Diagnostic test

    Also called 18F-rhPSMA-7.3 (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.

Study groups in NCT05413850
Study groupRoleWhat they receive
Phase 1, Cohort AExperimentalSubjects with PSMA positive disease will receive 5.55GBq of 177Lu-rhPSMA-10.1 (maximum of 3 cycles).
Receives: Drug: Lutetium (177Lu) rhPSMA-10.1 Injection; Diagnostic Test: 18F-rhPSMA-7.3 injection (in phase 1 only)
Phase 1, Cohort BExperimentalSubjects with PSMA positive disease will receive 7.4GBq of 177Lu-rhPSMA-10.1 (maximum of 3 cycles).
Receives: Drug: Lutetium (177Lu) rhPSMA-10.1 Injection; Diagnostic Test: 18F-rhPSMA-7.3 injection (in phase 1 only)
Phase 2, Cohort 2AExperimentalSubjects 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.
Receives: Drug: Lutetium (177Lu) rhPSMA-10.1 Injection
Phase 2, Cohort 2BExperimentalSubjects 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.
Receives: Drug: Lutetium (177Lu) rhPSMA-10.1 Injection
Phase 2, Cohort 2C (optional)ExperimentalIf 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.
Receives: Drug: Lutetium (177Lu) rhPSMA-10.1 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1 Incidence of DLTs

    Incidence of DLTs during the DLT observation period.

    Measured: 6 weeks post final IMP

  2. Phase 1 Frequency and nature of TEAEs

    Frequency and nature of treatment-emergent adverse events (TEAEs).

    Measured: End of study

  3. Phase 2 Evaluate the efficacy of Lutetium (177Lu) rhPSMA-10.1 Injection

    The number of subjects with an anti-tumour response defined as ≥50% reduction in PSA level from baseline to the end of treatment.

    Measured: 6 weekly intervals

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2022
  2. Study start20 Jul 2022
  3. Primary completion27 Aug 2026 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Non Randomized (Phase 1) and Randomized (Phase 2)
Masking
None (open label)
Enrolment
82 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05413850
Sponsor's protocol ID
BET-PSMA-121
Status last verified
May 2026
First submitted
20 May 2022
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38164586

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lutetium (177Lu) rhPSMA-10.1 Injection and 18F-rhPSMA-7.3 injection (in phase 1 only) in people with Prostate Cancer and Metastatic Castration-resistant Prostate Cancer, run by Blue Earth Therapeutics Ltd at 21 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United Kingdom, United States, Germany, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Blue Earth Therapeutics (+44 (0)1865 634500, contact@blueearthTx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1 Incidence of DLTs (time frame: 6 weeks post final IMP). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05413850, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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