None listed
Conditions
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.
Interventions
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 st
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.
Sponsors
Amplificare Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed