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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04726033




Registration number
NCT04726033
Ethics application status
Date submitted
14/10/2020
Date registered
27/01/2021

Titles & IDs
Public title
64Cu-TLX592 Phase I Safety, PK, Biodistribution and Dosimetry Study (CUPID Study)
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
Secondary ID [1] 0 0
64Cu-TLX592-001
Universal Trial Number (UTN)
Trial acronym
CUPID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Timepoint [1] 0 0
Day 1 to 28
Primary outcome [2] 0 0
Pharmacokinetics of 64Cu-TLX592
Timepoint [2] 0 0
Day 1-4 after a single administration of 64Cu-TLX592
Primary outcome [3] 0 0
Biodistribution of 64Cu-TLX592
Timepoint [3] 0 0
Up to 24h after a single administration of 64Cu-TLX592
Primary outcome [4] 0 0
Dosimetry of 64Cu-TLX592
Timepoint [4] 0 0
Up to 5 days after a single administration of 64Cu-TLX592
Secondary outcome [1] 0 0
Optimal antibody dose of TLX592
Timepoint [1] 0 0
Single diagnostic administration 1 day, followed by a diagnostic scan on Day 1
Secondary outcome [2] 0 0
Comparison of PSMA-targeting of different PMSA-imaging agents
Timepoint [2] 0 0
Single diagnostic administration 1 day, followed by a diagnostic scan on Day 1.

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.
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/01/2024
Sample size
Target
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Envision Medical Imaging - Perth
Recruitment hospital [2] 0 0
GenesisCare Wembly - Perth
Recruitment postcode(s) [1] 0 0
6014 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Telix Pharmaceuticals (Innovations) Pty Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04726033