Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04726033
Registration number
NCT04726033
Ethics application status
Date submitted
14/10/2020
Date registered
27/01/2021
Date last updated
1/05/2024
Titles & IDs
Public title
64Cu-TLX592 Phase I Safety, PK, Biodistribution and Dosimetry Study (CUPID Study)
Query!
Scientific title
A Phase I, Single Centre, Open-label Study of TLX592 to Assess the Safety and Tolerability, Pharmacokinetics, Biodistribution and Radiation Dosimetry in Patients Diagnosed With Prostate Cancer
Query!
Secondary ID [1]
0
0
64Cu-TLX592-001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
CUPID
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Metastatic Prostate Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Prostate
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - 64Cu-DOTA-TLX592
Experimental: Dose level 1 of 64Cu-TLX592 - Three patients will be intravenously administered with a single injection of 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu
Experimental: Dose level 2 of 64Cu-TLX592 - Three patients will be intravenously administered with a single injection of 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu combined with 8mg of unlabelled TLX592 (mass dose of 10mg).
Experimental: Dose level 3 of 64Cu-TLX592 - Three patients will be intravenously administered with a single injection of 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu combined with 18mg of unlabelled TLX592 (mass dose of 20mg).
Experimental: Confirmation of optimal 64Cu-TLX592 dose - Based on the result of Groups 1-3, the optimal dose and imaging timepoints will be selected to treat 3 patients with higher tumour burden (=10 metastatic sites and/or visceral disease as detected on a 68Ga-PSMA-11 or 18F-DCFPyl PSMA PET/CT scan).
Three patients will be intravenously administered with a single injection of 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu combined with 0, 8 or 18mg of unlabelled TLX592.
Treatment: Drugs: 64Cu-DOTA-TLX592
TLX592, a humanised, engineered monoclonal antibody HuX592r conjugated with a DOTA chelator and radiolabelled with 64Cu (64Cu-TLX592)
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Query!
Assessment method [1]
0
0
Treatment emergent adverse events (TEAE) will be classified according to MedDRA (Medical Dictionary for Regulatory Activities), frequency, severity according to NCI CTCAE V5.0, seriousness, and relationship of study treatment will be assessed. Laboratory abnormalities will be assessed according to the NCI CTCAE v.5.0
Query!
Timepoint [1]
0
0
Day 1 to 28
Query!
Primary outcome [2]
0
0
Pharmacokinetics of 64Cu-TLX592
Query!
Assessment method [2]
0
0
Patient plasma samples at 0h, 1h, 4 ± 0.5h, 20 ± 4h and 48 ± 4h after the administration of 64Cu-TLX592 will be counted for radioactivity.
Query!
Timepoint [2]
0
0
Day 1-4 after a single administration of 64Cu-TLX592
Query!
Primary outcome [3]
0
0
Biodistribution of 64Cu-TLX592
Query!
Assessment method [3]
0
0
On Days 0, Day 1 and potentially at 36-120h after administration of the investigational product, the biodistribution and tumour imaging will be performed. An end of study visit will be conducted on Day 28 ± 2 days. 64Cu-TLX592 images will be centrally analysed for absorbed organ and whole body doses in a standardised fashion. In addition, tumour absorbed doses will be determined for scientific purposes (estimation of achievable tumour doses of therapeutic nuclides labelled to TLX592)
Query!
Timepoint [3]
0
0
Up to 24h after a single administration of 64Cu-TLX592
Query!
Primary outcome [4]
0
0
Dosimetry of 64Cu-TLX592
Query!
Assessment method [4]
0
0
For dosimetry analysis, biodistribution whole body PET/CT imaging will be performed at 1h, 4 ± 0.5h, 20 ± 4h, with the option for a an additional two scans to be performed between the 36-120 hours.
Query!
Timepoint [4]
0
0
Up to 5 days after a single administration of 64Cu-TLX592
Query!
Secondary outcome [1]
0
0
Optimal antibody dose of TLX592
Query!
Assessment method [1]
0
0
The optimal antibody mass dose and its effect on the biological clearance of 64Cu- TLX592 from blood and radiation dose to tumour will be conducted on Day 0, Day 1 and potentially at 36-120h. The optimal antibody mass dose will be performed using gated or list mode acquisition, for generation of sub-partitioned data. Such data will allow the mathematical generation of statistically independent images for various dose levels, based on the actual dose administered in the trial.
Query!
Timepoint [1]
0
0
Single diagnostic administration 1 day, followed by a diagnostic scan on Day 1
Query!
Secondary outcome [2]
0
0
Comparison of PSMA-targeting of different PMSA-imaging agents
Query!
Assessment method [2]
0
0
To evaluate the comparability of PET images and PSMA-targeting characteristics between 64Cu-TLX592 and 68Ga-PSMA-11 and 18F-DCFPyl PSMA imaging agents.
Query!
Timepoint [2]
0
0
Single diagnostic administration 1 day, followed by a diagnostic scan on Day 1.
Query!
Eligibility
Key inclusion criteria
- Written informed consent.
- Biochemically recurrent metastatic adenocarcinoma of the prostate, or metastatic
primary adenocarcinoma of the prostate.
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of prostate.
- PSMA-expressing prostate adenocarcinoma as seen on 68Ga-PSMA-11 or 18F- DCFPyl PSMA
PET/CT scanning within the last 1 month showing PSMA-avid disease.
- ECOG performance status of 0 - 1.
- Normal organ function and marrow reserve:
- White blood cell (WBC) count = 2.5 x 109/L or absolute neutrophil count (ANC) = 1.5 x
109/L.
- Platelets = 100 x 109/L.
- Haemoglobin = 90g/L.
- Bilirubin < 1.5 x upper limit of normal (ULN) (or if bilirubin is between 1.5 - 2x
ULN, must have a normal conjugated bilirubin).
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 2.0 x ULN (or
- 5.0 x ULN in the presence of liver metastases).
- Serum creatinine = 1.5 x ULN or creatinine clearance = 60 mL/min.
Query!
Minimum age
No limit
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
A patient is excluded from participation in the trial if one or more of the following
criteria are met:
- Known active brain metastases.
- Serious active infection (as assessed by investigator).
- Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or
haematological organ systems which might preclude completion of this study or
interfere with determination of causality of any adverse effects experienced in this
study.
- Known or suspected allergies, hypersensitivity, or intolerance to the IMP or its
excipients.
- Other investigational agents within 4 weeks of randomization.
- Radiotherapy or immunotherapy within 4 weeks prior to the planned administration of
64Cu-TLX592 or continuing adverse effects (> grade 1) from such therapy [Common
Terminology Criteria for Adverse Events (CTCAE) version 5].
- Previous administration of any radionucleotide within 10 half-lives of 64Cu.
- Inability to understand, or unwilling to sign, a written informed consent document or
to follow investigational procedures in the opinion of the investigator.
- Patients who are unable to maintain self-care.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 0
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
4/08/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
29/01/2024
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
14
Query!
Recruitment in Australia
Recruitment state(s)
WA
Query!
Recruitment hospital [1]
0
0
Envision Medical Imaging - Perth
Query!
Recruitment hospital [2]
0
0
GenesisCare Wembly - Perth
Query!
Recruitment postcode(s) [1]
0
0
6014 - Perth
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Telix Pharmaceuticals (Innovations) Pty Limited
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a Phase 1 trial of TLX592, a humanised, engineered monoclonal antibody HuX592r
conjugated with a DOTA chelator and radiolabelled with 64Cu (64Cu-TLX592). TLX592 is being
developed as a PSMA-targeting antibody to be radiolabelled with a therapeutic radiosotope for
the treatment of PSMA-expressing tumours, therefore this study has been designed to assess
the safety and tolerability, pharmacokinetics, whole body biodistribution and radiation
dosimetry of 64Cu-TLX592.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04726033
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04726033
Download to PDF