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Trial registered on ANZCTR


Registration number
ACTRN12624001047583
Ethics application status
Approved
Date submitted
2/08/2024
Date registered
29/08/2024
Date last updated
15/09/2024
Date data sharing statement initially provided
29/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1/2 study to evaluate tumour cell death using CDI-DX001 PET/CT in pancreatic ductal adenocarcinoma
Scientific title
A two-part, Phase 1/2, open label study to evaluate tumour cell death using CDI-DX001 positron emission tomography/computed tomography (PET/CT) as a prognostic disease marker, a measure of response to neoadjuvant therapy and, as a potential novel theranostic treatment modality in pancreatic ductal adenocarcinoma (PDAC) patients
Secondary ID [1] 312576 0
CDI-DX001-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Ductal Adenocarcinoma 334495 0
Condition category
Condition code
Cancer 331113 331113 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CDI-DX001 is an investigational radiopharmaceutical for imaging of multiple forms of cell death using PET/CT in near real time.

Participants will be administered CDI-DX001 as a bolus by intravenous (IV) infusion with a target dose of 1.8-2.2 MBq/kg (minimum 111MBq, maximum 259 MBq). Administration of CDI-DX001 and all procedures related to this study will be performed by scientifically and medically qualified persons at an investigational site suitable for conducting human oncology imaging studies of this nature.

Study participants will undergo an approximately 30 minute PET/CT at 60 minutes ± 6 minutes post CDI-DX001 administration. All eligible study participants will undergo a baseline CDI-DX001 PET/CT scan, to occur within 14 days (Day -14 to Day -1) prior to commencing scheduled SoC treatment on Day 1. SoC treatment may involve NAC or NACRT, such as but not limited to FOLFIRINOX or gemcitabine plus Abraxane ± RT as directed by the treating medical and radiation oncologists. FDG PET/CT will also be performed as part of SoC assessments, prior to commencing scheduled systemic SoC treatment.

There will be 2 post-baseline sans for participants in Part 1 (Phase 1). The first post baseline CDI-DX001 PET/CT will occur 3-7 days (+1 day) following commencement of SoC treatment (i.e., after first dose of NAC). A second post baseline CDI-DX001 PET/CT will occur 17-21 days (+1 day) following commencement of SoC treatment (i.e., after first dose of NAC). There will be 1 post-baseline scans for participants in Part 2 (Phase 2), at a timepoint determined by data collected and analysed for Part 1 (Phase 1). No dose modifications of CDI-DX001 are permitted.

All participants will be followed up until completion of the final CDI-DX001 PET/CT scan, including an assessment to monitor for AEs and concomitant medication use up to 7 (+1) days after the last CDI-DX001 PET/CT scan that may be performed by telephone contact between site staff and the participant if an onsite visit is not already scheduled as part of the participant’s routine oncologic clinical care, and final assessments per the SoA at 16 weeks post initiation of SoC treatment. Additional unscheduled assessments and visits may occur at the discretion of the investigator.
Intervention code [1] 329097 0
Diagnosis / Prognosis
Intervention code [2] 329098 0
Treatment: Drugs
Comparator / control treatment
Measures obtained from CDI-DX001 PET/CT scans will be compared with current standard of care assessment outcomes. Standard of care assessments obtain information such as progress of treatment, physical function, vital signs, and laboratory values. FDG PET/CT will also be performed as part of SoC assessments, prior to commencing scheduled systemic SoC treatment.
Control group
Active

Outcomes
Primary outcome [1] 338875 0
Assess the level of uptake of CDI-DX001 at baseline.
Timepoint [1] 338875 0
At baseline (within 14 days prior to commencing Standard of Care (SoC) treatment).
Primary outcome [2] 339092 0
Assess the level of uptake of CDI-DX001 post commencement of SoC treatment.
Timepoint [2] 339092 0
At 3-7 (+1) days post start of SoC, and 17-21 (+1) days post start of SoC.
Secondary outcome [1] 437757 0
Assess biodistribution of CDI-DX001 in normal tissue, including major target organs.
Timepoint [1] 437757 0
At baseline (within 14 days prior to commencing SoC treatment), 3-7 (+1) days post start of SoC, and 17-21 (+1) days post start of SoC.
Secondary outcome [2] 437758 0
Assess the safety and tolerability of CDI-DX001 in a PDAC population. This will be assessed as a composite outcome.
Timepoint [2] 437758 0
Blood samples collected within 28 days prior to the first (baseline) CDI-DX001 PET/CT scan, after CDI-DX001 PET/CT at 3-7 (+1) days post start of SoC, and after CDI-DX001 PET/CT at 17-21 (+1) days post start of SoC.

ECG completed within 28 days prior to the first (baseline) CDI-DX001 PET/CT scan, before and after CDI-DX001 PET/CT at 3-7 (+1) days post start of SoC, before and after CDI-DX001 PET/CT at 17-21 (+1) days post start of SoC.

Vital signs monitored within 28 days prior to the first (baseline) CDI-DX001 PET/CT scan, before and after baseline CDI-DX001 PET/CT (within 14 days prior to commencing SoC treatment), before and after CDI-DX001 PET/CT at 3-7 (+1) days post start of SoC, before and after CDI-DX001 PET/CT at 17-21 (+1) days post start of SoC.

Complete physical examination conducted within 28 days prior to the first (baseline) CDI-DX001 PET/CT scan.

Limited physical examination conducted before and after CDI-DX001 PET/CT at 3-7 (+1) days post start of SoC, before and after CDI-DX001 PET/CT at 17-21 (+1) days post start of SoC.

ECOG PS recorded within 28 days prior to the first (baseline) CDI-DX001 PET/CT scan, after CDI-DX001 PET/CT at 3-7 (+1) days post start of SoC, after CDI-DX001 PET/CT at 17-21 (+1) days post start of SoC.
Secondary outcome [3] 438554 0
Assess SoC measures of PDAC progression and treatment response.
Timepoint [3] 438554 0
At baseline (within 14 days prior to commencing SoC treatment), and every 4 weeks following initiation of SoC treatment, up to 16 weeks (±1 week) post initiation of treatment.
Secondary outcome [4] 438904 0
Assess tumour response to SoC treatment.
Timepoint [4] 438904 0
RECIST assessments conducted at screening within 28 days prior to the first (baseline) CDI-DX001 PET/CT scan, and at follow up as directed for routine oncologic clinical care until the participant undergoes surgery or until 12 months (±2 weeks) post start of SoC treatment, whichever is the later, with an optional extension visit at 24 months (±4 weeks) following start of SoC treatment.
Secondary outcome [5] 438913 0
Assess patient outcomes
Timepoint [5] 438913 0
Follow up until the participant undergoes surgery or until 12 months (±2 weeks) following initiation of the participant’s SoC treatment, whichever is the later, with an optional extension visit at 24 months (±4 weeks) following start of SoC treatment.
Secondary outcome [6] 438919 0
Assess pre-study morphological imaging
Timepoint [6] 438919 0
Within 28 days prior to the first (baseline) CDI-DX001 PET/CT scan.

Eligibility
Key inclusion criteria
1. Male or female participants (or LAR) have voluntarily agreed to study participation by giving written informed consent and must be greater or equal to 18 years of age on the day of signing the informed consent form (ICF).
2. Participants with newly diagnosed histologically or cytologically confirmed Pancreatic Ductal Adenocarcinoma (PDAC) from one of the following 3 patient groups:
a. Group 1: Patients with borderline resectable (BR) disease with intent to undergo neoadjuvant chemotherapy (NAC) ± radiotherapy (RT).
b. Group 2: Patients with locally advanced unresectable disease with intent to undergo systemic treatment ± radiotherapy (RT).
c. Group 3: Patients with metastatic disease with intent to receive systemic treatment.
3. Participants must have radiologically measurable disease as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Eisenhauer 2009) at screening, with PDAC primary lesion greater or equal to 2 cm in maximum transaxial dimension (for Group 1 and Group 2) OR at least one lesion greater or equal to 2 cm in maximum transaxial dimension (for Group 3) based on pre-study morphological imaging evidence (FDG PET/CT, CT or MRI), not older than 30 days at screening.
4. Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of =1 at screening.
5. Life expectancy greater or equal to 12 weeks at screening according to investigator’s best judgement.
6. Adequate renal function characterised by estimated glomerular filtration rate (eGFR) >30 mL/min/1.73 m^2.
7. Female participants are eligible to enter and participate in the study if they are of:
a. Nonchildbearing potential.
b. Childbearing potential as defined in Appendix 1 of the protocol, with a negative pregnancy test at screening and within 7 days of the first CDI-DX001 PET/CT scan and agree to use contraception for the duration of the CDI-DX001 PET/CT imaging period.
c. Not breastfeeding.
8. Male participants who are sexually active with a woman of child bearing potential are eligible to enter and participate in the study if they are vasectomised or agree to the use of
contraception (as defined in Appendix 1 of the protocol) for the duration of the CDI-DX001 PET/CT imaging period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Female participants who are pregnant or lactating.
2. Participants receiving:
a. Any prior systemic chemotherapy.
b. Biologic therapy (i.e., antibodies), continuous or intermittent small-molecule therapies, or any other investigational agents within a period of 5 times the half life of the agent or within 4 weeks (whichever is shorter) prior to day of first CDI-DX001 PET/CT scan.
c. For participants with borderline resectable (BR)-Pancreatic Ductal Adenocarcinoma (PDAC) or locally advanced (LA)-PDAC, any prior curative or palliative radiotherapy (RT).
d. For participants with metastatic PDAC, prior curative or palliative radiation therapy to all measurable sites of disease > 2 cm (i.e. no assessable sites of disease >2 cm which have not received radiotherapy (RT)).
e. Any major surgery within 4 weeks prior to the day of first CDI-DX001 PET/CT scan.
3. Known or suspected hypersensitivity to CDI-DX001 or any of its components.
4. Concurrent participation in another therapeutic clinical trial.
5. Exposure to any radiopharmaceutical with a half-life greater than 99mTc within up to 7 days prior to the first planned administration of CDI-DX001 dependent on the radioisotope (e.g., if 18F, 68Ga or 99mTc up to 16 hours is sufficient).
6. Active uncontrolled infection at screening.
7. Congestive heart failure or prior cardiac disease per New York Heart Association Classification III or IV.
8. Uncontrolled hypertension (systolic blood pressure [BP] >180 mmHg or diastolic BP >100 mmHg)
9. Any active malignancy less or equal to 3 years before the first CDI-DX001 PET/CT scan except for the specific cancer under investigation in this study or any localised or noninvasive cancer that has been treated curatively (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, treated early stage melanoma, or carcinoma in situ of the prostate, cervix or breast).
10. Any other unstable, preexisting major medical condition that in the opinion of the investigator contraindicates the use of CDI-DX001, or otherwise renders the participant unfit for the study, in the opinion of the investigator, after medical interview, physical examination, and/or screening investigations.

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 / Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/12/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 317007 0
Commercial sector/Industry
Name [1] 317007 0
Amplificare Pty Ltd
Country [1] 317007 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Amplificare Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 319251 0
None
Name [1] 319251 0
Address [1] 319251 0
Country [1] 319251 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315766 0
Bellberry Human Research Ethics Committee G
Ethics committee address [1] 315766 0
https://bellberry.com.au/
Ethics committee country [1] 315766 0
Australia
Date submitted for ethics approval [1] 315766 0
07/08/2024
Approval date [1] 315766 0
11/09/2024
Ethics approval number [1] 315766 0

Summary
Brief summary
Study purpose:
The aim of this study is to evaluate tumour cell death and its potential to predict patient outcomes, to assess efficacy of neoadjuvant chemotherapy and radiotherapy, and as a potential novel theranostic treatment modality in pancreatic ductal adenocarcinoma (PDAC) patients.

Who is it for?
Newly diagnosed, histologically or cytologically confirmed PDAC patients (male or female) 18 years or older will be recruited to this study after an initial referral from participating oncology centres.

Study details:
Participants will be administered CDI-DX001 as a bolus by intravenous (IV) infusion. Study participants will be scanned using PET/CT 60 mins post CDI-DX001 administration. There will be 3 scans in total for participants in Phase 1, and 2 scans for participants in Phase 2, over a period of 4-6 weeks. No dose modifications of CDI-DX001 are permitted. Patients' uptake of CDI-DX001, progress of treatment, physical function, vital signs, and laboratory values will be assessed.

It is hoped that findings from this study will provide an efficient, accurate, and minimally invasive method to characterise and monitor PDAC, and inform new methods of treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135722 0
Prof David Goldstein
Address 135722 0
Prince of Wales Hospital, Level 1, Bright Building, Barker Street, Randwick NSW 2031
Country 135722 0
Australia
Phone 135722 0
+61 2 9382 5111
Fax 135722 0
Email 135722 0
[email protected]
Contact person for public queries
Name 135723 0
Rob Daniels
Address 135723 0
Amplificare Pty Ltd c/o Brandon Capital Partners, Suite 2.05, 1 York Street Sydney, NSW 2000 Australia
Country 135723 0
Australia
Phone 135723 0
+61 2 424 439 481
Fax 135723 0
Email 135723 0
[email protected]
Contact person for scientific queries
Name 135724 0
A/Prof Ivan Ho Shon
Address 135724 0
Dept of Nuclear Medicine & PET, Level 2, Campus Centre, Prince of Wales Hospital, Barker St, Randwick 2031
Country 135724 0
Australia
Phone 135724 0
+61 2 9382 2200
Fax 135724 0
Email 135724 0
[email protected]

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

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No documents have been uploaded by study researchers.

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