NCT05413850

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P75+ for phase_1 prostate-cancer

Timeline
23mo left

Started Jul 2022

Typical duration for phase_1 prostate-cancer

Geographic Reach
5 countries

23 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jul 2022Mar 2028

First Submitted

Initial submission to the registry

May 20, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

July 20, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2026

Expected
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

4.1 years

First QC Date

May 20, 2022

Last Update Submit

April 8, 2026

Conditions

mCRPCUrogenital NeoplasmsProstatic NeoplasmsProstate CancerMetastatic Castration-resistant Prostate CancerProstatic Diseases

Keywords

PSMAmCRPCProstate cancer177Lu rhPSMA-10.118F-rhPSMA-7.3BET-PSMA-121Blue Earth Therapeutics LimitedRadiohybridRadiopharmaceuticals

Outcome Measures

Primary Outcomes (3)

  • Phase 1 Incidence of DLTs

    Incidence of DLTs during the DLT observation period.

    6 weeks post final IMP

  • Phase 1 Frequency and nature of TEAEs

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

    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.

    6 weekly intervals

Study Arms (5)

Phase 1, Cohort A

EXPERIMENTAL

Subjects with PSMA positive disease will receive 5.55GBq of 177Lu-rhPSMA-10.1 (maximum of 3 cycles).

Drug: Lutetium (177Lu) rhPSMA-10.1 InjectionDiagnostic 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).

Drug: Lutetium (177Lu) rhPSMA-10.1 InjectionDiagnostic 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.

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.

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.

Drug: Lutetium (177Lu) rhPSMA-10.1 Injection

Interventions

18F-rhPSMA-7.3 injection (in phase 1 only)DIAGNOSTIC_TEST

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.

Also known as: 18F-rhPSMA-7.3 (in phase 1 only)
Phase 1, Cohort APhase 1, Cohort B
Lutetium (177Lu) rhPSMA-10.1 InjectionDRUG

Therapeutic cycles of 177Lu-rhPSMA-10.1

Also known as: 177Lu-rhPSMA-10.1
Phase 1, Cohort APhase 1, Cohort BPhase 2, Cohort 2APhase 2, Cohort 2BPhase 2, Cohort 2C (optional)

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Biogenix Molecular LLC

Miami, Florida, 33165, United States

RECRUITING

NovaCure Health

Miami, Florida, 33176, United States

RECRUITING

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

XCancer Omaha / Urology Cancer Center

Omaha, Nebraska, 68130, United States

RECRUITING

Weill Cornell Medicine - New York - Presbyterian Hospital

New York, New York, 10065, United States

COMPLETED

Jules Bordet Institute

Brussels, 1000, Belgium

WITHDRAWN

Saint Luc University Hospital

Brussels, 1200, Belgium

RECRUITING

University Hospital Ghent

Ghent, 9000, Belgium

RECRUITING

University Hospital Leuven

Leuven, Belgium

RECRUITING

University Hospital Center Sart-Tilman

Liège, 4000, Belgium

WITHDRAWN

University Hospital Aachen

Aachen, Germany

RECRUITING

Universitätsklinikum Augsburg

Augsburg, Germany

RECRUITING

University Hospital Essen

Essen, Germany

RECRUITING

Hospital Rechts der Isar

Munich, Germany

RECRUITING

Radboud UMC

Nijmegen, Gelderland, 6525GA, Netherlands

RECRUITING

Meander Medisch Centrum

Amersfoort, Netherlands

RECRUITING

Bristol Hematology and Oncology Center

Bristol, BS2 8ED, United Kingdom

RECRUITING

Beatson West of Scotland Cancer Center

Glasgow, G12 0YN, United Kingdom

RECRUITING

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

RECRUITING

James Cook University Hospital

Middlesbrough, TS4 3BW, United Kingdom

RECRUITING

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

RECRUITING

Weston Park

Sheffield, United Kingdom

RECRUITING

University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38164586DERIVED

Related Links

MeSH Terms

Conditions

Prostatic NeoplasmsUrogenital NeoplasmsProstatic Diseases

Interventions

LutetiumLutetium-177

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Lanthanoid Series ElementsMetals, Rare EarthElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Blue Earth Therapeutics

    Blue Earth Therapeutics

    STUDY DIRECTOR

Central Study Contacts

Blue Earth Therapeutics

CONTACT

+44 (0)1865 634500contact@blueearthTx.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Non Randomized (Phase 1) and Randomized (Phase 2)
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2022

First Posted

June 10, 2022

Study Start

July 20, 2022

Primary Completion (Estimated)

August 27, 2026

Study Completion (Estimated)

March 31, 2028

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(5)NL(2)GB(7)US(5)DE(4)