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ACTIVE NOT RECRUITING
NCT05121038
PHASE1/PHASE2

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

Sponsor: 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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2021-10-20

Completion Date

2026-09

Last Updated

2024-12-17

Healthy Volunteers

No

Interventions

DRUG

CEND-1

The treatment with CEND-1 will be given as an intravenous (IV) infusion (through a needle in a vein) at the clinic once every 14 days (or Day 1 of every 14-day cycle starting in Cycle 4).

DRUG

Panitumumab

Up to ten (10) participants with cancer that has spread to certain areas of the body and who have a certain gene in the tumor called "RAS/BRAF wild type" will receive another drug called panitumumab in addition to CEND-1 and FOLFIRINOX.

DRUG

Folfirinox

FOLFIRINOX is a name for a chemotherapy treatment regimen that includes several different drugs that are given in a certain order. All of these drugs are given as an intravenous (IV) infusion (through a needle in a vein) at the clinic once every 14 days (or Day 1 of every 14-day cycle). * Oxaliplatin - dose is 85 mg / m2 the infusion takes about 2 hours. then * Leucovorin - dose is 400 mg / m2 - this is given at same time with irinotecan (below) and the infusion takes about 1.5 hours. * Irinotecan - dose is 180 mg / m2 - this is given at same time with leucovorin (above), and the infusion takes about 1.5 hours. then • Fluorouracil - dose is 2400 mg / m2 - this infusion takes 46 to 48 hours (2 days) with an IV pump done at home.

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