A safety and early efficacy study of LSTA1 in combination with durvalumab, gemcitabine and nab-paclitaxel, as first-line treatment in locally advanced pancreatic ductal adenocarcinoma (PDAC)

ACTRN 12623000223639

Brief Summary

This study aims to assess the safety and tolerability of a new cancer treatment drug, LSTA1, in combination with durvalumab, gemcitabine and nab-paclitaxel, as first-line treatment for patients with locally advancedat a late stage, far along pancreatic ductal adenocarcinomacancer arising from mucus-producing glands in organs (PDAC).

Intervention/Treatment

• Drug: Gemcitabine.
• Drug: LSTA1.
• Drug: Durvalumab.

Inclusion Criteria

1. Have histologically confirmed locally advanced pancreatic ductal adenocarcinoma.
2. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent must be obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
3. Age > 18 years at time of study entry, age > 20 years for Japanese patients.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Have either adequate archival tissue from prior biopsyremoval of a section of tissue to analyse for cancer cells for biomarker evaluation or willingness to undergo biopsy before treatment starts and willing to have biopsy during treatment at 12 weeks (if appropriate).
6. Have a negative serum pregnancy test (if a premenopausal female subject). Men and women of child-bearing potential must be willing to use effective contraceptive methods during the study, Section 9.1.5.
7. Adequate normal organ and marrow function as defined below:
   • Haemoglobin greater than or equal to 9.0 g/dL.
   • Absolute neutrophil count (ANC) greater than or equal to 1.5 × 10^9 /L.
   • Platelet count greater than or equal to 100 × 10^9/L.
   • Serum bilirubin less than or equal to 1.5 x institutional upper limit of normal (ULN).
   • AST (SGOT)/ALT (SGPT) less than or equal to 3 x institutional upper limit of normal.
   • Measured creatinine clearance (CL) >60ml/min/1.73 m2 or calculated creatinine Cl >40mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance.
8. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
9. Must have a life expectancy of at least 12 weeks.
10. Have no clinically significant abnormalities on urinalysis.
11. Have acceptable coagulation status:
    • Prothrombin time (PT) within normal limits.
    • Partial Thromboplastin Time (PTT) within normal limits.
12. At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumour assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to randomisation.

Must be eligible for treatment with nab-paclitaxel and gemcitabine