None listed
Conditions
Brief summary
This is a phase 1 study of a new molecule (called CEND-1) designed to enter cancer cells and increase the uptake of chemotherapy drugs. Who is it for? You may be eligible for this study if you are aged over 18 and have histologically confirmed metastatic pancreatic ductal cancer. Study details Participants in the phase 1a of the study will take the study medication CEND-1 alone initially for one week, before commencing a combination therapy with CEND-1 and the 28-day cycle of chemotherapy. Participants in the phase 1b of the study will receive the combination therapy with CEND-1 and the 28-day cycle of chemotherapy directly. Treatment may continue as long as there is perceived benefit or until disease progression. All participants will provide blood samples and undergo imaging studies. All participants will receive standard doses of chemotherapy, nabpaclitaxel and gemcitabine, approved in Australia. The primary goal of this research study is to find the correct dose of the study drug, CEND-1, that can be given alone or in combination with standard chemotherapy to patients with pancreatic cancer that has spread. Another goal is to measure the levels of CEND-1 in the blood over time. Researchers also want to learn if the study drug combinations can help to control the disease.
Interventions
This is an open-label, multicenter, dose-escalation, safety, pharmacodynamic, pharmacokinetic study of CEND-1 in combination with nabpaclitaxel and gemcitabine administered weekly for three weeks followed by one week off over 28 days.
This protocol is designed to evaluate the safety, tolerability, and biologic activity of CEND-1 in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who are undergoing a combination therapy with nabpaclitaxel and gemcitabine. CEND-1 is a tumor-penet
This is an open-label, multicenter, dose-escalation, safety, pharmacodynamic, pharmacokinetic study of CEND-1 in combination with nabpaclitaxel and gemcitabine administered weekly for three weeks followed by one week off over 28 days. This protocol is designed to evaluate the safety, tolerability, and biologic activity of CEND-1 in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who are undergoing a combination therapy with nabpaclitaxel and gemcitabine. CEND-1 is a tumor-penetrating peptide (scientifically also known as iRGD) that activates a drug transport mechanism specifically in tumors. Study involves an initial dose escalation phase (1a) with four different CEND-1 dose levels, first as a monotherapy (during 1-week run-in), followed by a combination therapy with CEND-1 and nabpaclitaxel and gemcitabine (one 28-day treatment cycle). A subsequent expansion phase (1b) with approximately 28 subjects will assess the safety, tolerability and preliminary efficacy of the combination treatment using two different CEND-1 dose levels (14 subjects / dose level). Cohort 1a (Dose Escalation): Run-in Period (7 days) - CEND-1 will be given intravenously as a slow IV push over 1 minute on day 1 of the run-in period. Treatment Cycle 1 - On the second week after enrolling, treatment will commence with Cycle 1 of nabpaclitaxel followed by CEND-1 and gemcitabine (intravenous administration, one 28-day treatment cycle). Cohort 1b (Safety/early efficacy): Cohort 1b will explore safety and early efficacy with two CEND-1 dose levels (selected based on cohort 1a) in combination with nabpaclitaxel and gemcitabine (all agents intravenously). Treatment cycles will be repeated every 4 weeks based on toxicity and response. Treatment may continue as long as there is perceived benefit or until disease progression. Study completion will be no later than when all patients have completed six (6) cycles. The Sponsor will continue to provide CEND-1 to patients who remain on active treatment without evidence of significant treatment-related toxicities or clinical evidence of progressive disease at study closure.
Sponsors
DrugCendR Australia Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with histologically confirmed metastatic pancreatic ductal carcinoma One or more metastatic lesions measurable on MRI, PET/CT, or dedicated CT scan according to RECIST v1.1. Eligible for treatment with nabpaclitaxel and gemcitabine Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 Life expectancy of at least 3 months Adequate archival tissue from prior biopsy for biomarker evaluation or willingness to undergo biopsy before treatment starts The patient is capable of understanding and complying with the protocol and the subject or, when applicable, the subject's legally acceptable representative has signed the informed consent A negative serum pregnancy test (if a premenopausal female patient) Acceptable liver function: Bilirubin equal or less than 1.5 times upper limit of normal; AST (SGOT) less than 10 times upper limit of normal, ALT (SGPT) and Alkaline phosphatase equal or less than 2.5 times upper limit of normal (if liver metastases are present, then equal or less than 5 times upper limit is allowed). Acceptable renal function: Serum creatinine within normal limits AND calculated creatinine clearance equal or more than 60 mL/min/1.73 per square meter for patients with creatinine levels above institutional normal by the Cockroft-Gault equation. Acceptable hematologic status: Granulocyte equal or more than 1500 cells/mm3; Platelet count equal or more than 100,000 plt per square millimetre; Hemoglobin equal or more than 9 g/dL. Urinalysis: No clinically significant abnormalities. Acceptable coagulation status: PT within normal limits; PTT within normal limits. For men and women of child-producing potential, the use of effective contraceptive methods during the study.
Exclusion criteria
New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy Pregnant or nursing women. Women of child-bearing potential and men must agree to use adequate contraception. Unwillingness or inability to comply with procedures required in this protocol Known infection with HIV, hepatitis B, or hepatitis C Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions per physician judgement) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
Outcome results
None listed