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.
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
- Conditions the study is for
- Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, mCRPC
- 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
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.
21 sites in 5 countries
United Kingdom7 sites, 7 recruiting
- 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
United States5 sites, 4 recruiting
- 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
- Completed
Weill Cornell Medicine - New York - Presbyterian Hospital
New York, New York, 10065
- Recruiting
XCancer Omaha / Urology Cancer Center
Omaha, Nebraska, 68130
Nordquist, (402) 991-8468, drnordquist@gucancer.com
Luke Nordquist, MD
Germany4 sites, 4 recruiting
- 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
Belgium3 sites, 3 recruiting
- 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
Netherlands2 sites, 2 recruiting
- 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
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.
- Conditions
- Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, mCRPC, Urogenital Neoplasms, Prostatic Neoplasms, Prostatic Diseases
- 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 group | Role | What they receive |
|---|---|---|
| Phase 1, Cohort A | Experimental | Subjects 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 B | Experimental | Subjects 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 2A | Experimental | 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. Receives: Drug: Lutetium (177Lu) rhPSMA-10.1 Injection |
| Phase 2, Cohort 2B | Experimental | 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. Receives: Drug: Lutetium (177Lu) rhPSMA-10.1 Injection |
| Phase 2, Cohort 2C (optional) | Experimental | 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. 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.
Phase 1 Incidence of DLTs
Incidence of DLTs during the DLT observation period.
Measured: 6 weeks post final IMP
Phase 1 Frequency and nature of TEAEs
Frequency and nature of treatment-emergent adverse events (TEAEs).
Measured: End of study
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.
- First posted10 Jun 2022
- Study start20 Jul 2022
- Primary completion27 Aug 2026 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Blue Earth Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PSI CRO
- Responsible party
- Sponsor
- Investigators
- Blue Earth Therapeutics, Study director, Blue Earth Therapeutics Ltd
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