Health TrialsbyHealthPanel

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

ConditionsProstate CancerMetastatic Castration-resistant Prostate CancermCRPCUrogenital NeoplasmsProstatic NeoplasmsProstatic Diseases
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorBlue Earth Therapeutics Ltd

About this trial

To determine the dose, safety, radiation dosimetry and efficacy of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Lutetium (177Lu) rhPSMA-10.1 Injection

    Drug

    Therapeutic cycles of 177Lu-rhPSMA-10.1

  • 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.

Treatment groups

82 Participants
are divided into 5 treatment groups
Group A: Phase 1, Cohort AExperimental treatment 2 interventions
Group B: Phase 1, Cohort BExperimental treatment 2 interventions
Group C: Phase 2, Cohort 2AExperimental treatment 1 intervention
Group D: Phase 2, Cohort 2BExperimental treatment 1 intervention
Group E: Phase 2, Cohort 2C (optional)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1 Incidence of DLTs

Incidence of DLTs during the DLT observation period.

Time frame
6 weeks post final IMP
2

Phase 1 Frequency and nature of TEAEs

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

Time frame
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.

Time frame
6 weekly intervals

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Blue Earth Therapeutics Ltd

Lead sponsor

PSI CRO

Collaborator

Source ClinicalTrials.gov
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