iLSTA

Protocol Title

A Phase 1 single-blind study evaluating LSTA1 in combination with durvalumab, gemcitabine and nab-paclitaxel as a first-line treatment in locally advanced pancreatic ductal adenocarcinoma.

Purpose of study

To determine the safety and tolerability of the addition of LSTA1 when added to the combination of durvalumab, gemcitabine, and nab-paclitaxel in subjects with locally advanced pancreatic ductal adenocarcinomas.

Eligibility Criteria

Main Inclusion Criteria:

1. Have histologically confirmed locally advanced pancreatic ductal adenocarcinoma.
2. Both males and females. Age > 18 years at time of study entry, age > 20 years for Japanese patients.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Have either adequate archival tissue from prior biopsy for biomarker evaluation or willingness to undergo biopsy before treatment starts and willing to have biopsy during treatment at 12 weeks (if appropriate)
5. 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
6. Adequate normal organ and marrow function

Main Exclusion Criteria:

1. Have received any prior chemotherapy, immunotherapy, or any other investigational agents for the treatment of pancreatic cancer.
2. Concurrent enrolment in another clinical study unless it is an observational (non- interventional) clinical study or during the follow-up period of an interventional study.
3. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
4. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
5. History of allogenic organ transplantation.
6. Active or prior documented autoimmune or inflammatory disorders
7. Uncontrolled intercurrent illness
8. History of another primary malignancy except for
a. Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence.
b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
c. Adequately treated carcinoma in situ without evidence of disease
9. History of leptomeningeal carcinomatosis
10. History of active primary immunodeficiency
11. Known to have tested positive for human immunodeficiency virus (HIV)
12. Known to have active tuberculosis infection.
13. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP

Contact Email

admin@warpnine.org.au

Principal investigator

Dr Andrew Dean

Detailed information available

Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) please click here.

Funding

Philanthropically funded by WARPNINE