Trial purpose
Cancer treatment
Tumor type
Upper gastrointestinal tract
Age
18+
Clinical summary
Summary
This trial involves a does escalation and expansion phase. In the dose escalation phase, participants will receive three different CEND-1 dose levels, first as a monotherapy and followed by combination therapy with nabpaclitaxel and gemcitabine. In the dose expansion phase, approximately 28 subjects will receive combination treatment with two different CEND-1 dose levels.
Conditions
This trial is treating people with exocrine pancreatic cancer
Eligibility
Inclusion
- 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 ≥ 1.5 times upper limit of normal; AST (SGOT) < 10 times upper limit of normal, ALT (SGPT) and Alkaline phosphatase 2.5 times upper limit of normal (if liver metastases are present, then ≤ 5 x ULN is allowed).
- Acceptable renal function: Serum creatinine within normal limits; calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal by the Cockroft-Gault equation.
- Acceptable hematologic status: Granulocyte ≥ 1500 cells/mm3; Platelet count ≥ 100,000 plt/mm3; Hemoglobin ≥ 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
- Prior chemotherapy or any other investigational agents for the treatment of pancreatic cancer.
- Concurrent use of any other anti-cancer therapy, including chemotherapy, targeted therapy, immunotherapy, or biological agents.
- Participants with known brain metastases.
- 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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
DrugCendR
Scientific Title
A Phase 1 Clinical Trial of CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Exocrine Pancreatic Cancer
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