Study of RM-1929 and Photoimmunotherapy in Patients With Recurrent Head and Neck Cancer

Completed · Phase 1/Phase 2

Conditions studied: Recurrent Head and Neck Cancer

In brief

This is a two-part clinical study of patients with recurrent Head and Neck Cancer (HNC), who in the opinion of their physician, cannot be satisfactorily treated with surgery, radiation or platinum chemotherapy. The purpose of the study is to determine the safety and anti-cancer activity of various doses and repeated cycles of the experimental treatment using the study drug RM-1929 and fixed amounts of red light applied at the tumor site to activate the pharmacodynamics of the drug. The part 1 of the study has been completed and consisted in a single cycle, 3+3 dose escalation safety study of the experimental drug RM-1929 using a fixed amount of 690 nm red light. The part 1 was designed to determine the safety of the treatment as set by the maximal feasible dose or the maximal tolerable dose of RM-1929. From the part 1 results, the maximal feasible dose of RM-1929 was determined. The part 2 of the study is currently ongoing and it is evaluating the safety and anticancer efficacy of up to four repeated treatments of Photoimmunotherapy with RM-1929 at the maximal feasible dose of RM-1929 activated with a fixed amount of red light.

Key facts

Study ID

NCT02422979

Run by

Rakuten Medical, Inc.

People needed

40

Starts

2015-06-01

Expected to finish

2019-02-25

Last updated by the study team

2020-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet the following criteria to be eligible for study participation:
• Patients with recurrent squamous carcinoma of the Head and Neck, who in the opinion of their treating physician, cannot be satisfactorily treated with surgery, radiation, or platinum chemotherapy. Diagnosis must be confirmed by biopsy and histopathology.
• Patient must have received prior systemic platinum-based chemotherapy for treatment of their head and neck cancer, unless in the opinion of the medical oncologist, the use of platinum-based chemotherapy is contraindicated or not recommended, e.g., renal impairment, allergy to platinum compounds, age, liver disease, myelosuppression, neuropathy, hearing loss, etc.
• Patients must have life expectancy > 6 months based on investigator judgment.
• Male or female patients at least 18 years old. Female patients must not be pregnant or breast feeding and must be practicing a medically acceptable form of birth control, be sterile, or post-menopausal. Females of childbearing potential (FCBP) is defined as premenopausal women capable of becoming pregnant. This includes women who are post-menopausal for at least 12 months after the last menses. FCBP must agree to use a medically acceptable form of birth control during the study and for at least 6 months after discontinuation of Erbitux® or study medication. Females must agree not to breast feed during the study and for at least two months after discontinuation of Erbitux® or study medication. Male patients should be using a double barrier protection method that is a medically acceptable form of birth control during the study or be sterile.
• Patients must have an ECOG score of 0 - 2.
• Patient must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.

You may not qualify if…

• Patients with any of the following will be excluded from participation in the study:
• Patients with a history of significant Erbitux infusion reactions (≥ Grade 3).
• Patients on chemotherapy or Erbitux® therapy or radiation therapy within 4 weeks of enrollment.
• Tumor invading a major blood vessel (such as the carotid artery) unless the vessel has been embolized, stented or surgically ligated to prevent hemorrhage.
• Tumor is not clearly shown on a CT scan or clinically measurable.
• Location and extension of the tumor precludes an effective PIT.
• Patients with impaired hepatic function (ALP (hepatic), AST and/or ALT >3 times the upper normal limits, or total serum bilirubin > 2 mg/dL.
• Patients with impairment of renal function (serum creatinine >2 mg/dL).
• Unwilling or unable to follow protocol requirements.
• Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patient requires examinations or treatments within 4 weeks after study drug administration where they would be exposed to significant light, e.g., eye examinations, surgical procedures, endoscopy, etc.

Where it is running

• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Centura Health Research Center — Denver, Colorado, United States
• Rush University Cancer Center — Chicago, Illinois, United States
• Virginia Piper Cancer Institute, part of Allina Health System — Minneapolis, Minnesota, United States
• University of Oklahoma Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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