A PHASE I CLINICAL STUDY IN THE UNITED STATES TO EVALUATE RM-1929 FOR USE IN PATIENTS WITH RECURRENT HEAD AND NECK CANCER

RM-1929 is an investigational drug—a drug that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA). The red laser device used to activate RM-1929  activity is also an investigational device that has not been approved for sale in the United States by the FDA.

WHAT IS THE CLINICAL RESEARCH STUDY ABOUT?

The current treatment for people with recurrent head and neck cancers is radiation, chemotherapy, and surgery. However, individuals who experience relapse or are refractory to these treatments have limited options for further treatment.
 
Aspyrian Therapeutics is developing a drug, RM-1929, for recurrent head and neck cancer patients. This clinical trial is registered on www.clinicaltrials.gov under the registration identifier NCT02422979.
 
Patients who can qualify to enroll in this study include patients with head and neck cancers of the oral cavity (lips, tongue, gums, cheeks, and floor plate), pharynx (oropharynx, nasopharynx, and hypopharynx), larynx, nasal cavity, and face. 

 

WHO IS ELIGIBLE TO PARTICIPATE?

participate

Participants in this study will be people who have recurring head and neck cancer and can no longer be treated with surgery, radiation, or platinum chemotherapy based on the opinion of their regular doctor.

GET IN TOUCH

If you or someone you know has recurrent head and neck cancer and is interested in participating in the study, please fill the form below to receive information on the enrollment process. Please note that the information submitted below will be kept strictly confidential by Aspyrian Therapeutics, Inc. and will not be shared with any third party entity. 

Are you a head and neck cancer patient? *
Are you interested in enrolling the study? *

WHAT IS THE CLINICAL RESEARCH STUDY ABOUT?

The current treatment for people with recurrent head and neck cancers is radiation, chemotherapy, and surgery. However, individuals who experience relapse or are refractory to these treatments have limited options for further treatment.
 
Aspyrian Therapeutics is developing a drug, RM-1929, for recurrent head and neck cancer patients. This clinical trial is registered on www.clinicaltrials.gov under the registration identifier NCT02422979.
 
Patients who can qualify to enroll in this study include patients with head and neck cancers of the oral cavity (lips, tongue, gums, cheeks, and floor plate), pharynx (oropharynx, nasopharynx, and hypopharynx), larynx, nasal cavity, and face. 

WHO IS ELIGIBLE TO PARTICIPATE?

Participants in this study will be people who have recurring head and neck cancer and can no longer be treated with surgery, radiation, or platinum chemotherapy based on the opinion of their regular doctor.

WHAT ARE THE CLINICAL INVESTIGATION STEPS FOR ENROLLED PARTICIPANTS?

The study involves two dosing procedures followed by a few follow-up outpatient visits to the hospital to monitor the study participant. 
 
1) The dosing procedure includes two outpatient clinical site visits:
    a) RM-1929 infusion: RM-1929 is administered through intravenous infusion. 
 
    b) Red light illumination with a laser: At 24 hours after RM-1929 infusion, red light produced from a laser is applied locally at the tumor site to activate the RM-1929 and to induce the rapid killing of the cancer. The red light is used only to activate RM-1929 within the tumor. 
 
2) The follow-up visits includes three outpatient clinical site visits.

 

HOW LONG WILL THE STUDY TAKE?

The total duration for an enrolled study participant is one month. However, the study participant will not be required to stay in the hospital for the entire month. The clinical study is based on an outpatient procedure, in which the study participant will be asked to visit the clinical site for a total of five visits during the course of the study.

 

WHAT ARE THE POTENTIAL RISKS FOR STUDY PARTICIPANTS?

Study participants may experience side effects while on the research study. Side effects may include mild to severe local swelling and/or pain, which may affect speaking, breathing, or swallowing; bleeding; shortness of breath; chest pain; dehydration; blood electrolyte changes; hypotension or weight loss. Side effects may be mild or very serious, and brief or longstanding. Study participants may also experience additional unknown side effects.

 

WHERE ARE THE CLINICAL TRIAL LOCATIONS?

The clinical studies are taking place in various hospitals within the United States.

WHO WILL BE PAYING FOR THE STUDY?

Aspyrian Therapeutics, Inc. is paying for this study. 
Aspyrian Therapeutics, Inc.11189 Sorrento Valley Rd, Suite 104 San Diego CA 92121, USA

WHAT IS RM-1929 AND HOW DOES IT WORK?

RM-1929 is a modification of a FDA approved anti-cancer drug called Erbitux®. RM-1929 attaches to and accumulates in head and neck tumors more than in normal tissues. RM-1929 can be activated with red light and possibly results in the rapid local destruction of head and neck tumors.