sEphB4-HSA With RT+Chemo or Cetux in Patients With Intermediate to High Risk LAHNSCC

PHASE1CompletedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

January 6, 2020

Primary Completion Date

May 14, 2021

Study Completion Date

October 25, 2022

Conditions
Squamous Cell Carcinoma of Head and Neck
Interventions
DRUG

sEphB4-HSA with chemotherapy

sEphB4-HSA is a fusion protein combining the soluble extracellular EphB4 domain with albumin that targets the ephrin B2 receptor, which is thought to mediate resistance to EGFR-targeted therapy, and acts as a radiosensitizer by enhancing DNA damage and promoting apoptosis. Concurrent chemotherapy drug (either cisplatin or carboplatin): Per treating physician discretion, and treatment plan is based per NCCN guidelines. These can be administered in tri-weekly or weekly doses during the radiation period. The participant will receive the first infusion on Day 15 (+/- 3 days).

DRUG

Cetuximab

Loading dose 400 mg/m2 on D9 Concurrent dose 250mg/m2 weekly D15± 3 day window

RADIATION

Radiation Therapy

6930 cGy IMRT starting D15-D18

Trial Locations (1)

80045

University of Colorado Hospital, Aurora

All Listed Sponsors
collaborator

Vasgene Therapeutics, Inc

INDUSTRY

lead

University of Colorado, Denver

OTHER

NCT04091867 - sEphB4-HSA With RT+Chemo or Cetux in Patients With Intermediate to High Risk LAHNSCC | Biotech Hunter | Biotech Hunter