Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000921482
Ethics application status
Approved
Date submitted
27/06/2025
Date registered
25/08/2025
Date last updated
25/08/2025
Date data sharing statement initially provided
25/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluate the relative uptake of 68Ga-3BP-6146 in tumour and normal tissues in patients with selected advanced solid tumours
Scientific title
Imaging of advanced solid tumours using 68Ga-3BP-6146: Effectiveness of a novel imaging agent (68Ga-3BP-6146) in detecting solid tumour lesions in adults with advanced non-small-cell lung, breast, or gastrointestinal cancer.
Secondary ID [1] 314764 0
Nil known
Universal Trial Number (UTN)
Trial acronym
3BP uPAR Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced non-small-cell lung cancer 337985 0
Advanced breast cancer 337986 0
Advanced gastrointestinal cancer 337987 0
Condition category
Condition code
Cancer 334302 334302 0 0
Lung - Non small cell
Cancer 334305 334305 0 0
Breast
Cancer 334306 334306 0 0
Other cancer types
Cancer 334375 334375 0 0
Stomach
Cancer 334376 334376 0 0
Oesophageal (gullet)
Cancer 334377 334377 0 0
Bowel - Small bowel (duodenum and ileum)
Cancer 334378 334378 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 334379 334379 0 0
Bowel - Anal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Non-radioactive active pharmaceutical ingredient 3BP-6146 is supplied in form of lyophilized solid to Quantum Pharma Australia Pty Ltd. Australian and local regulations for producing radiopharmaceuticals from active pharmaceutical ingredients and subsequent quality control testing apply.
A single dose of 200 MBq (+/-10%) 68Ga-3BP-6146 will be administered as an intravenous bolus injection under the supervision of the study Investigator or appropriately qualified delegate on Day 1 of the study. The line may be flushed with 0.9% sodium chloride before and after the end of injection, per institutional guidelines. Premedications may be administered per Investigator discretion.
Low dose PET/CT imaging will be done at 1 hour (+/-15 minutes) and 4 hours (+/-30 minutes) post administration of the dose. Each scan will take approximately 16 minutes to complete.
Adherence and fidelity to the intervention are monitored through regular audits of nursing and medical documentation, as well as review of study data collected in source documents and CRFs. Only qualified personnel who have completed protocol-specific training are authorised to prepare and administer the investigational radiopharmaceutical. Administration procedures are supported by standardised checklists and a double-check process to ensure compliance with the protocol and maintain patient safety.
Intervention code [1] 331368 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341965 0
To characterize the tumour uptake of 68Ga-3BP-6146 in patients with advanced non-small-cell lung, breast or gastrointestinal cancer (except neuroendocrine tumours).
Timepoint [1] 341965 0
1 and 4 hours post dose.
Primary outcome [2] 342059 0
To characterize the uptake and wash out of 68Ga-3BP-6146 in normal organs (eg. liver, kidneys, duodenum). This is a composite outcome.
Timepoint [2] 342059 0
1 and 4 hours post dose.
Secondary outcome [1] 449164 0
To evaluate the safety of 68Ga-3BP-6146
Timepoint [1] 449164 0
Adverse events will be assessed and recorded during screening, before dosing, immediately after dosing, 1 hour after dosing, 4 hours after dosing and 48 hours after dosing. The focus of post-dose adverse event reporting will be on any treatment emergent adverse events, defined as any adverse events that occurs after the first dose of study drug up to 48 hours after IP administration.

Eligibility
Key inclusion criteria
1) Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.
2) Adult participant’s 18 years of age or older.
3) Histologically confirmed diagnosis of advanced non-small-cell lung, breast, or gastrointestinal cancer (except neuroendocrine tumours). Tumors must have progressed during or after the most recent line of anticancer therapy.
4) Signed, written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Have any medical condition that would, in the Investigator’s judgment, prevent the participant’s full participation in the clinical study due to safety concerns or compliance with clinical study procedures
2) Currently taking anticancer therapy with evidence of disease stabilization.
3) History of allergic reactions and/or known or expected hypersensitivity to peptide therapeutics, including 68Ga-3BP-6146 or any of its excipients.
4) Inadequate organ function as reflected in laboratory parameters:
- Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 60 mL/min or serum creatinine >1.5 x upper limit of normal (ULN)
- Platelet count of < 75 x 109/L
- Absolute neutrophil count (ANC) < 1.0 x 109/L
- Haemoglobin < 8 g/dL
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x ULN, or > 5 x ULN for patients with known liver metastases
- Total bilirubin > 1.5 x ULN, except for patients with documented Gilbert’s syndrome who are eligible if total bilirubin less than or equal to 3 x ULN

Study design
Purpose of the study
Diagnosis
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
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The study is exploratory. The goal of evaluating up to 20 patients is to provide a preliminary assessment of 68Ga-3BP-6146 uptake in tumours and normal organs.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/08/2025
Actual
Date of last participant enrolment
Anticipated
30/01/2026
Actual
Date of last data collection
Anticipated
30/01/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 28150 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 44358 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 319316 0
Commercial sector/Industry
Name [1] 319316 0
3B Pharmaceuticals GmbH
Country [1] 319316 0
Germany
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Sydney
Address
Country
Australia
Secondary sponsor category [1] 321795 0
None
Name [1] 321795 0
Address [1] 321795 0
Country [1] 321795 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317896 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 317896 0
Ethics committee country [1] 317896 0
Australia
Date submitted for ethics approval [1] 317896 0
12/07/2024
Approval date [1] 317896 0
23/10/2024
Ethics approval number [1] 317896 0

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

Contacts
Principal investigator
Name 142494 0
Prof Louise Emmett
Address 142494 0
St Vincent's Hospital, Sydney, Theranostics & Nuclear Medicine Dept, 390 Victoria St. Darlinghurst NSW 2010
Country 142494 0
Australia
Phone 142494 0
+61 411 331 065
Fax 142494 0
Email 142494 0
[email protected]
Contact person for public queries
Name 142495 0
Louise Emmett
Address 142495 0
St Vincent's Hospital, Sydney, Theranostics & Nuclear Medicine Dept, 390 Victoria St. Darlinghurst NSW 2010
Country 142495 0
Australia
Phone 142495 0
+610283821830
Fax 142495 0
Email 142495 0
[email protected]
Contact person for scientific queries
Name 142496 0
Louise Emmett
Address 142496 0
St Vincent's Hospital, Sydney, Theranostics & Nuclear Medicine Dept, 390 Victoria St. Darlinghurst NSW 2010
Country 142496 0
Australia
Phone 142496 0
+610283821830
Fax 142496 0
Email 142496 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.