Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000620426
Ethics application status
Approved
Date submitted
20/05/2025
Date registered
13/06/2025
Date last updated
22/06/2025
Date data sharing statement initially provided
13/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1, First-In-human PET imaging study to assess [68Ga]Ga-AB101 in participants with Advanced Solid Tumours
Scientific title
A Phase 1, Open-label, First-in-human, Positron Emission Tomography (PET) Imaging Study to Assess the Biodistribution and safety of  [68Ga]Ga-AB101 in participants with Advanced Solid Tumours. 
Secondary ID [1] 314398 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced solid tumours 337408 0
Condition category
Condition code
Cancer 333784 333784 0 0
Oesophageal (gullet)
Cancer 333782 333782 0 0
Breast
Cancer 333785 333785 0 0
Head and neck
Cancer 333783 333783 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an open-label, non-controlled, interventional Phase 1 clinical study of a gallium-68 (68Ga) labelled PET imaging tracer in patients with solid tumours who have received treatment with at least one prior chemotherapy, or targeted therapy, or immuno-oncology agent.
This study will include only participants who have one of the following tumour types: TNBC, sqNSCLC, OSCC, or HNSCC.
The study will initially assess imaging and pharmacokinetics (PK) of [68Ga]Ga-AB101 in up to 10 participants with any of the carcinoma indications).
Depending on the results, the study will continue to assess imaging and PK of [68Ga]Ga-AB101 in up to 5 participants in each of the carcinoma indications

[68Ga]Ga-AB101 will be administered once, as a single intravenous injection, by a qualified nuclear medicine physician or nuclear medicine technologist.
This will be followed by 3 -4 PET/CT scans up to 6 hours post-dose. The administered activity is calculated based on body weight, at a dose of 2 MBq/Kg.
At least 3 scans will be done. A 4th scan may be done depending on how clearly the image shows the actual body tissue compared to region to the background.
The first scan will take about 30mins and the other scans will take approximately 30 min.
Intervention code [1] 331007 0
Diagnosis / Prognosis
Comparator / control treatment
PET Imaging conducted in conjunction with study imaging agent administration will be compared to conventional imaging that was done as part of standard of care for each of the participants. The conventional imaging should have occurred within 28 days prior to study imaging agent administration.
Control group
Active

Outcomes
Primary outcome [1] 341769 0
To evaluate the biodistribution and lesion uptake of study imaging agent
Timepoint [1] 341769 0
Whole-body PET/CT over 30min , 1h, 2h and 4-6hr post dose.
Primary outcome [2] 341366 0
To evaluate the biodistribution and lesion uptake of study imaging agent
Timepoint [2] 341366 0
Whole-body PET/CT over 30min , 1h, 2h and 4-6hr post dose.
Secondary outcome [1] 447329 0
To evaluate the pharmacokinetics of study imaging agent
Timepoint [1] 447329 0
15min-, 1h-, 2h- and optionally, 4-6h post-dose
Secondary outcome [2] 447332 0
To determine the safety and tolerability profile of a single administration of study imaging agent
Timepoint [2] 447332 0
Day 1 post-dose and Day 6 (+/- 2 days) post-dose
Secondary outcome [3] 447331 0
To determine the concordance of lesions detected by PET/CT of study imaging agent and conventional imaging (CT, MRI, etc)
Timepoint [3] 447331 0
Following conclusion of PET/CT scans on Day 1, post-dose
Secondary outcome [4] 447330 0
To characterise the PET imaging performance and lesion targeting of study imaging agent
Timepoint [4] 447330 0
Over 30min period post-dose, 1h-, 2h and optionally, 4-6h post-dose

Eligibility
Key inclusion criteria
1. 18 years of age or over and capable of giving signed informed consent
2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.
3.Locally advanced or metastatic carcinoma with histological confirmation of one of the following indications: triple negative breast cancer (TNBC), squamous non-small cell lung cancer (sqNSCLC), oesophageal squamous cell carcinoma (OSCC), head and neck squamous cell carcinoma (HNSCC).
4. Availability of an archival tumour sample for immunohistochemical (IHC) analysis.
5. Previous treatment requirements: at least one prior chemotherapy, or targeted therapy or immuno-oncology agent.
6. Presence of at least one [fluorine-18 (18F)]fluorodeoxyglucose (FDG) PET-avid, non-necrotic lesion measuring at least 1 cm with no prior radiation therapy within 28 days before study imaging agent administration.
7. Adequate bone marrow, renal, and hepatic function.
8. Participants must agree to use highly effective contraception during the study and for 30 days after the last dose of study imaging agent. Male participants must also agree to refrain from donating sperm during and fathering a child until 90 days after the last dose of study imaging agent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability or unwillingness to undergo PET/CT imaging.
2. Bladder outflow obstruction or unmanageable urinary incontinence.
3. A known additional malignancy that has required active treatment within the past 2 years before start of the study, except for adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ that has undergone curative therapy.
4. Active clinically serious infection or serious non-healing wound, ulcer, or bone fracture.
5. Major surgery or significant trauma within 4 weeks before start of study.
6. Impaired cardiac function or clinically significant cardiac disease.
7. Known allergies, hypersensitivity, or intolerance to PET/CT tracers or compounds similar to the study imaging agent (including excipients).
8. Administration of a radiopharmaceutical within five half-lives of the radionuclide used prior to injection of the study imaging agent.
9. Prior radiotherapy completed less than two weeks before the start of study.
10. Concurrent participation in the active treatment part of another clinical study with IMP(s).

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
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/06/2025
Actual
Date of last participant enrolment
Anticipated
15/12/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318917 0
Commercial sector/Industry
Name [1] 318917 0
ARTBIO Pty Ltd
Country [1] 318917 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
ARTBIO Pty Ltd
Address
Country
United States of America
Secondary sponsor category [1] 321386 0
None
Name [1] 321386 0
Address [1] 321386 0
Country [1] 321386 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317534 0
Bellberry Human Research Ethics Committee D
Ethics committee address [1] 317534 0
Ethics committee country [1] 317534 0
Australia
Date submitted for ethics approval [1] 317534 0
16/04/2025
Approval date [1] 317534 0
27/05/2025
Ethics approval number [1] 317534 0

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

Contacts
Principal investigator
Name 141350 0
Prof Rodney Hicks
Address 141350 0
Melbourne Theranostic Innovation Centre, Level 8/14-20 Blackwood St, North Melbourne VIC 3051
Country 141350 0
Australia
Phone 141350 0
+61394545800
Fax 141350 0
Email 141350 0
[email protected]
Contact person for public queries
Name 141351 0
Mohana Suppiah-Coll
Address 141351 0
ARTBIO Inc., One Kendall Square, B200, Suite 001, Cambridge, MA 02139
Country 141351 0
United States of America
Phone 141351 0
+447394036594
Fax 141351 0
Email 141351 0
[email protected]
Contact person for scientific queries
Name 141352 0
Jenna M. Sullivan
Address 141352 0
ARTBIO Inc., One Kendall Square, B200, Suite 001, Cambridge, MA 02139
Country 141352 0
United States of America
Phone 141352 0
+17742810847
Fax 141352 0
Email 141352 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.