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)

Phase 1

Recruiting

• Conditions: Cancer; Cancer - Pancreatic

• Registration Number: ACTRN12623000223639
• Lead Sponsor: Warpnine Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-02
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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 biopsy 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:
a.Haemoglobin greater than or equal to 9.0 g/dL
b.Absolute neutrophil count (ANC) greater than or equal to 1.5 × 10^9 /L
c.Platelet count greater than or equal to 100 × 10^9/L
d.Serum bilirubin less than or equal to 1.5 x institutional upper limit of normal (ULN).
e.AST (SGOT)/ALT (SGPT) less than or equal to 3 x institutional upper limit of normal.
f.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:
a.Prothrombin time (PT) within normal limits
b.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

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, investigational product (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. 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.
4.History of allogenic organ transplantation.
5.Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc]).
6.Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
7.History of another primary malignancy
8.History of leptomeningeal carcinomatosis
9.Mean QT interval corrected for heart rate using Fridericia’s formula (QTcF) greater than or equal to 470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart) Regardless of whether this criteria stays or not, all patients should have a baseline ECG
10.History of active primary immunodeficiency
11.Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HbsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of anti-HBc and absence of HbsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
12.Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies.
13.Known to have active tuberculosis
14.Have a history of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on baseline chest CT scan.
15.Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
16.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

Study & Design

• Study Type: Interventional
• Study Design: Not specified