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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05720130
Registration number
NCT05720130
Ethics application status
Date submitted
7/01/2023
Date registered
9/02/2023
Date last updated
3/11/2023
Titles & IDs
Public title
Dose Escalation and Efficacy Study of 212Pb-ADVC001 in Patients With Metastatic Castration Resistant Prostate Cancer.
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Scientific title
TheraPb: Phase I/IIa Dose Escalation and Toxicity Study of [212Pb]Pb-ADVC001 in Metastatic Prostate Adenocarcinoma
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Secondary ID [1]
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TheraPb-ADVC001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms
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Castration-Resistant
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - [212Pb]Pb-ADVC001
Experimental: [212Pb]Pb-ADVC001 - There is only a single treatment arm. Participants with metastatic Castration Resistant Prostate Cancer that have received prior Androgen Receptor Pathway Inhibitors (e.g., Abiraterone, Enzalutamide) and chemotherapy (or can have declined chemotherapy), who have not been previously treated with [177Lu]Lu-PSMA radioligand therapy. Four cohorts will receive escalating doses of 60 MBq, 90 MBq, 120MBq and 150MBq of [212Pb]Pb-ADVC001. Participants will receive a dose via intravenous injection every 6 weeks (+/- 2 weeks) for no more than 4 cycles.
Treatment: Drugs: [212Pb]Pb-ADVC001
[212Pb]Pb-ADVC001 administered intravenously under the dose escalation schedule
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), assessed in accordance with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
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Assessment method [1]
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Timepoint [1]
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Up to Week 36
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Primary outcome [2]
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Incidence and severity of dose-limiting toxicities, assessed in accordance with NCI CTCAE V5.
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Assessment method [2]
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Timepoint [2]
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Up to Week 6
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Primary outcome [3]
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Frequency of clinically significant changes from baseline in clinical chemistry and hematology laboratory values.
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Assessment method [3]
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Timepoint [3]
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Up to Week 36
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Primary outcome [4]
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Maximum tolerated dose (MTD) of [212Pb]Pb-ADVC001, assessed using the standard 3+3 dose escalation design.
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Assessment method [4]
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Timepoint [4]
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Up to 6 weeks
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Primary outcome [5]
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Recommended Phase 2 Dose (RP2D) for [212Pb]Pb-ADVC001.
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Assessment method [5]
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The RP2D is defined as the dose level that is well tolerated in patients. This will be equal or less than the MTD. In the case where an MTD is not identified, even at the highest dose level tested, the RP2D may be determined based on data indicating adequate tolerability and therapeutic effectiveness.
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Timepoint [5]
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Through study completion, estimated 12 months study duration.
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Secondary outcome [1]
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Whole body biodistribution and organ radiation dosimetry of [212Pb]Pb-ADVC001
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Assessment method [1]
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Absorbed radiation doses to kidneys, liver, lungs, spleen, and salivary glands.
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Timepoint [1]
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Up to Week 19
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Secondary outcome [2]
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Whole body biodistribution and organ radiation dosimetry of [212Pb]Pb-ADVC001
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Assessment method [2]
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Favourable and selective uptake of [212Pb]Pb-ADVC001 in PSMA-expressing tumours as determined by qualitative image read by expert radiologist or nuclear medicine physician, and, where possible, tumour-to-healthy tissue ratios.
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Timepoint [2]
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Up to Week 19
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Secondary outcome [3]
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Comparability of biodistribution of [212Pb]Pb-ADVC001 to PSMA targeting positron emission tomography (PET) imaging agents
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Assessment method [3]
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Biodistribution of [212Pb]Pb-ADVC001 and 68Ga-PSMA (or 18F based-PSMA), as determined by image interpretation by expert radiologist or nuclear medicine physician.
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Timepoint [3]
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Up to Week 19
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Secondary outcome [4]
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Radiographic progression free survival (rPFS)
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Assessment method [4]
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rPFS defined as the time from enrolment to the occurrence of one of the following:
Progression of measurable lesions using RECIST 1.1;
Progression of bone lesions using PCWG3 criteria;
Death due to any cause;
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Timepoint [4]
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Up to Week 25
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Secondary outcome [5]
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Objective response rate
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Assessment method [5]
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Objective response rate in patients with measurable disease (RECIST 1.1).
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Timepoint [5]
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Up to Week 25
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Secondary outcome [6]
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Prostate specific antigen (PSA) response
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Assessment method [6]
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PSA response defined as a reduction from baseline PSA level of at least 50%, maintained for at least 3 weeks.
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Timepoint [6]
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Up to Week 36
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Secondary outcome [7]
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Change from baseline in serum alkaline phosphatase (ALP) values.
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Assessment method [7]
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Timepoint [7]
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Up to Week 36
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Eligibility
Key inclusion criteria
- Male and 18 years of age or older at the time of signing the consent form with
metastatic adenocarcinoma of the prostate, confirmed by histopathology.
- Castration-resistant prostate cancer progressing or has progressed on androgen
receptor therapy.
- Had exposure to a taxane-based chemotherapy at any time in the course of their
disease, unless contraindicated or declined.
• Progressive disease with rising PSA level, or new lesion(s) in the viscera or lymph
nodes as per RECIST 1.1 or in bone as per Prostate Cancer Working Group 3.
- Significant PSMA avidity on 68Ga-PSMA PET/CT or 18F-based PSMA PET/CT (at least one
site of disease with maximum standardised uptake value (SUVmax) = 1.5 times the SUV of
normal liver).
- Eastern Cooperative Oncology Group (ECOG) Performance status 0 to 2.
- Adequate renal, bone and liver function (Absolute neutrophil count: =2 x 10^9/L ,
Hemoglobin: =90 g/L, Platelet count: >150,000 x 10^9/L, Serum creatinine: <1.5 x upper
limit of normal (ULN) i.e = 125 umol/L or calculated creatinine clearance = 60
mL/min/1.73 m2 by Cockcroft-Gault formula, Serum total bilirubin: <1.5 x ULN (unless
the patient has Gilbert's syndrome in which case direct bilirubin must be normal),
Serum aspartate aminotransferase (AST) and alanine transaminase (ALT): <1.5 x ULN in
the absence of liver metastases; <3 x ULN if due to liver metastases (in both
circumstances bilirubin must meet entry criteria).
- Estimated life expectancy >12 weeks
- Willing and able to comply with all study requirements, including the timing and
nature of all required assessments.
- Agree to practice adequate precautions to prevent pregnancy in a partner.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Prostate cancer with known significant sarcomatoid or spindle cell or neuroendocrine
small cell components.
- Sjogren's syndrome or other pathologies affecting salivary gland function.
- Prior treatment with radiopharmaceuticals containing the following radioisotopes:
lutetium-177, actinium-225, strontium-89, samarium-153, rhenium-186, rhenium-188,
radium-223 or other lead-212-containing radiopharmaceuticals.
- Received systemic anti-cancer therapy and/or radiation therapy within four weeks of
Screening.
- Received any investigational agent within four weeks of Screening.
- Contraindications to the use of corticosteroid treatment.
- Concurrent other malignancies that are expected to alter life expectancy or may
interfere with disease assessment.
- Known brain metastases of any size or hepatic metastases > 1 cm (longest diameter).
- Concurrent illness, including severe infection that may jeopardize the ability of the
patient to undergo the procedures outlined in this protocol with reasonable safety.
- Known alteration in breast cancer genes (BRCA) BRCA1, BRCA2 or Ataxia Telangiectasia
Mutated Gene (ATM), and are eligible to receive Olaparib therapy according to their
treating institution standard of care.
- Severe claustrophobia that may impact the participants ability to comply with all
aspects of the imaging protocol.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/03/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2024
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Actual
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Sample size
Target
18
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Royal Brisbane & Women's Hospital - Brisbane
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Recruitment hospital [2]
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Princess Alexandra Hospital - Brisbane
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Recruitment postcode(s) [1]
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4029 - Brisbane
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Recruitment postcode(s) [2]
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4102 - Brisbane
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AdvanCell Isotopes Pty Limited
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a first-in-human, dose escalation and efficacy study of [212Pb]Pb-ADVC001 in
participants with PSMA-positive metastatic Castration Resistant Prostate Cancer (mCRPC).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05720130
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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David Wyld
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Address
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Royal Brisbane & Women's Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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AdvanCell Isotopes Pty Limited
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Address
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Country
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Phone
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612 8000 4199
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05720130
Download to PDF