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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 20, 2021

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2026

Conditions
Colon CancerPancreas CancerDigestive Cancer
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."

Trial Locations (3)

64116

The University of Kansas Medical Center, North Kansas City

66205

The University of Kansas Cancer Center (KUCC), Fairway

The University of Kansas Cancer Center, Westwood Campus, Kansas City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Cend Therapeutics Inc.

UNKNOWN

lead

Anup Kasi

OTHER