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CEND-1 in Combination with Neoadjuvant FOLFIRINOX with or Without Panitumumab | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

CEND-1 in Combination with Neoadjuvant FOLFIRINOX with or Without Panitumumab

A Phase 1B/2A Trial of CEND-1 in Combination with Neoadjuvant FOLFIRINOX Based Therapies in Pancreatic, Colon and Appendiceal Cancers (CENDIFOX)

NCT05121038•Anup Kasi

View on ClinicalTrials.gov

Summary

This is a phase IB/IIA trial to ensure the safety of Certepetide (LSTA1/CEND-1) in combination with with Folfirinox with or without Panitumumab for treatment of pancreatic, colon and appendiceal cancers

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
•Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 1
•One or more lesions evaluable on MRI, positive emission tomography (PET)/CT, or dedicated CT scan according to RECIST v1.1
•Patients with histologically confirmed pancreatic ductal adenocarcinomas, colorectal and appendiceal adenocarcinomas
•For cohort 1: Resectable Pancreatic Cancer: No evidence of distant metastasis and tumor mass showing no extension to superior mesenteric artery (SMA) and hepatic artery. There must be clear fat plane between SMA and celiac axis. Patent superior mesenteric vein (SMV/portal vein (PV) with no distortion of venous architecture. Please refer to 2021 NCCN PDAC Guidelines
•For cohort 1: Borderline Resectable Pancreatic Cancer: defined as localized cancer with 1 or more of the following features: "a) an interface between the primary tumor and superior mesenteric vein (SMV)-portal vein (PV) measuring 180o or greater of the circumference of the vein wall, and/or b) short-segment occlusion of the SMV-PV with normal vein above and below the level of obstruction that is amenable to resection and venous reconstruction and/or c) short segment interface of any degree between tumor and hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and arterial reconstruction and/or d) an interface between the tumor and SMA or celiac trunk measuring less than 180o of the circumference of the artery wall. Please refer to 2021 National Comprehensive Cancer Network (NCCN) Pancreatic Ductal Adenocarcinoma (PDAC) Guidelines
•For cohort 2: Peritoneal Metastases due to Colorectal Cancer or Invasive Adenocarcinoma of the Appendix
•For cohort 3: Oligometastatic colorectal cancer: resectable metastases as determined by multidisciplinary evaluation. Patients with bilobar liver metastases or oligometastatic liver and lung metastases that requires resection of one or more metastases are also allowed
•Eligible for treatment with FOLFIRINOX with or without panitumumab
•Life expectancy of at least 3 months
+4 more criteria

Exclusion Criteria

•Simultaneously enrolled in any therapeutic clinical trial
•Concurrent use of any other anti-cancer therapy, including chemotherapy, targeted therapy, immunotherapy, or biological agents
•Prior chemotherapy or any other investigational agents for the treatment of cancer within 2 years prior to enrollment on this study
•Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
•Is pregnant or breastfeeding
•Has a known allergic reaction to any excipient contained in the study drug formulation
•Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment
•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
•Known infection with HIV, hepatitis B, or hepatitis C
•Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator
+4 more criteria

Locations (3)

The University of Kansas Cancer Center (KUCC)

Fairway, Kansas, United States

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, United States

The University of Kansas Medical Center

North Kansas City, Missouri, United States

Key Dates

Start Date

October 20, 2021

Primary Completion Date

September 1, 2025

Completion Date

September 1, 2026

Last Updated

December 17, 2024

Enrollment

ESTIMATED participants

Conditions

Colon CancerPancreas CancerDigestive Cancer

Interventions

CEND-1

DRUG

Panitumumab

DRUG

Folfirinox

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: December 17, 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 Neoadjuvant FOLFIRINOX with or Without Panitumumab

Inclusion Criteria

Exclusion Criteria

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