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CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Pancreatic Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Pancreatic Cancer

A Phase 1 Clinical Trial of CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Exocrine Pancreatic Cancer

NCT03517176•Lisata Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

CEND-1, Gemicitabine and Nab-Paclitaxel for Pancreatic Ductal Adenocarcinoma

Detailed Description

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 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 with four different CEND-1 dose levels, first as a monotherapy (during 1-week run-in), followed by combination therapy with nabpaclitaxel and gemcitabine (one 28-day treatment cycle). A subsequent expansion phase with approximately 28 subjects will assess the safety, tolerability and preliminary efficacy of the combination treatment using two different CEND-1 dose levels.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 ≥ 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.
+4 more criteria

Exclusion Criteria

•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.

Locations (3)

Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Alfred Hospital

Melbourne, Victoria, Australia

St John of God Hospital

Subiaco, Western Australia, Australia

Key Dates

Start Date

July 31, 2018

Primary Completion Date

June 19, 2020

Completion Date

June 19, 2020

Last Updated

August 28, 2024

Enrollment

ACTUAL participants

Conditions

Pancreatic CancerPancreatic Ductal Adenocarcinoma

Interventions

CEND-1

DRUG

Nab-paclitaxel

DRUG

Gemcitabine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

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