Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Head and neck cancer, excluding thyroid

2588 - A phase 1, multicenter, open-label, dose-escalation, combination study of RM-1929 and photoimmunotherapy in patients with recurrent head and neck cancer

Date

09 Sep 2017

Session

Head and neck cancer, excluding thyroid

Topics

Clinical Research;  Cancers in Adolescents and Young Adults (AYA);  Head and Neck Cancers

Presenters

Samith Thomas Kochuparambil

Citation

Annals of Oncology (2017) 28 (suppl_5): v372-v394. 10.1093/annonc/mdx374

Authors

S.T. Kochuparambil1, D. McDonald2, M. Fidler3, K. Stenson4, N. Vasan5, M.A. Razaq6

Author affiliations

  • 1 Oncology, Virginia Piper Cancer Institute, 55407 - Minneapolis/US
  • 2 Otolaryngology, Virginia Piper Cancer Institute, 55407 - Minneapolis/US
  • 3 Oncology, Rush University Medical Center, 60612 - Chicago/US
  • 4 Otolaryngology, Rush University Medical Center, 60612 - Chicago/US
  • 5 Otolaryngology, Stephenson Cancer Center OU, 73104 - Oklahoma City/US
  • 6 Oncology, Stephenson Cancer Center OU, 73104 - Oklahoma City/US
More

Resources

Abstract 2588

Background

Patients with recurrent head and neck squamous cell cancer (rHNSCC) have a poor prognosis once they have failed definitive treatment. We have completed a Phase 1 dose-escalation study of a unique targeted light activated drug conjugate RM1929 consisting of the EGFR-directed monoclonal antibody cetuximab conjugated to the phthalocyanine dye IRDye 700DX.

Methods

This was a Phase I study of rHNSCC patients who could not be satisfactorily treated with surgery, radiation, or platinum chemotherapy. The study included a drug dose-escalation with a fixed fluence light application to determine the drug dose that could be safely given to activate the pharmacodynamics of anticancer responses. Twenty-four hours after drug infusion non-thermal red light was applied to the tumors either on the surface for mucosal/skin disease or within the tumor via fiber optic diffusers for submucosal or nodal disease. Primary safety endpoints were assessed at 1 week and secondary efficacy endpoints were assessed at 1 month post treatment.

Results

Nine patients were enrolled in the 3 cohort dose escalation study. There were no dose-limiting toxicities and the drug dose and light fluence for treatment was determined. No photosensitivity reactions were observed at any drug dose during solar simulator testing. Four patients experienced 3 SAEs that were probably or possibly related to treatment including oral pain, tumor hemorrhage, and tumor pain. For 8 patients who were assessed for best overall response rate after a single cycle of treatment using clinical and RECIST 1.1, the objective response rate (ORR) was 75% (6/8) with 3 complete responses which were durable (4-16 months). The disease control rate was 100% (DCR). 7/8 patients showed a decrease in tumor density, consistent with post-treatment necrosis.

Conclusions

The phase 1 dose escalation study demonstrated the safety and tolerability of photoimmunotherapy with RM1929. We have observed improvement in clinically significant endpoints in patients with rHNSCC who do not have other treatment options.

Clinical trial identification

NCT02422979

Legal entity responsible for the study

FDA

Funding

Aspyrian Therapeutics

Disclosure

All authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.