Title: A Phase 1/2a Multicenter, Open-Label, Dose-Escalation, Combination Study of RM-1929 and Photoimmunotherapy in Patients With Recurrent Head and Neck Cancer, Who in the Opinion of Their Physician, Cannot Be Satisfactorily Treated With Surgery, Radiation or Platinum Chemotherapy1

Principal Investigators: John Campana, MD, Centura Health Research Center; Mary Jo Fidler, MD and Kerstin Stenson, MD, Rush University Cancer Center; Samith T Kochuparambil, MD, Virginia Piper Cancer Institute; Nilesh Vasan, MD, University of Oklahoma Stephenson Cancer Center; David Cognetti, MD, Thomas Jefferson University; Ann M Gillenwater, MD, University of Texas MD Anderson Cancer Center

Description: For this single-arm, phase 1/2, multi-center trial, researchers are evaluating the safety and efficacy of RM-1929, a “chemical conjugate composed of the dye IR700 linked to cetuximab,” combined with an activating near-infrared light, for patients with head and neck cancer.2

All enrolled patients must have cancer untreatable with surgery, radiotherapy, or platinum chemotherapy.

The phase 1, RM-1929 dose-escalation part of this study is complete, and researchers are recruiting for the phase 2 portion. For the phase 2 part, researchers are determining whether the maximum tolerated dose of RM-1929 combined with 4 photoimmunotherapy treatments using near-infrared light is safe and active in this patient group.

The primary endpoints of part 2 of this trial are the maximum tolerated/feasible dose of RM-1929 and infrared light, and safety with repeated photoimmunotherapy doses.

Secondary endpoints included tumor response and immunogenic response.

For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02422979.

Status: This study is open and recruiting patients as of July 10, 2017.

This study is sponsored by Aspyrian Therapeutics, Inc.

Reference

  1. Clinicaltrials.gov. Study of RM-1929 and photoimmunotherapy in patients with recurrent head and neck cancer. NCT02422979. https://clinicaltrials.gov/ct2/show/NCT02422979. Accessed July 10, 2017.
  2. Cetuximab-IR700 conjugate RM-1929. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=771602. Accessed July 10, 2017.