A Phase 1/2 study to evaluate tumour cell death using CDI-DX001 PET/CT in pancreatic ductal adenocarcinoma

Phase 1

• Conditions: Pancreatic Ductal Adenocarcinoma; Cancer - Pancreatic

• Registration Number: ACTRN12624001047583
• Lead Sponsor: Amplificare Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-29
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified