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

NCT02422979 | Completed Phase 1

• 1 other identifier: RM-1929/101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Recurrent Head and Neck Cancer

Outcome Measures

Primary Outcomes (5)

• Part I: Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD) of RM-1929, whichever is lowest

  Determine the MTD or MFD of RM-1929

  1 month

• Part I: Adverse Event profile for each drug dose of RM-1929

  Assessment of safety of the combination of drug dose with low energy localized light irradiation

  1 month

• Part I: Photosafety (sunburn) Testing

  Determination of skin Minimal Erythema Dose (MED) following infusion of RM-1929

  1 month

• Part II: Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD) of a fixed drug dose with fixed light dose

  Determination of MTD or MFD of fixed drug dose with fixed light dose

  1 month

• Part II: Safety with repeat dosing

  Safety parameters associated with repeat dosing

  2 years or until death

Secondary Outcomes (7)

• Part I: Tumor response

  2 months

• Part 1: Tumor reduction/necrosis

  2 month

• Part I: Pharmacokinetics of RM-1929 and for both RM-1929 and unconjugated IRDye 700DX (Cmax, T 1/2, AUC, CL and Vss)

  1 month

• Part I: Immunogenic response to RM-1929

  2 month

• Part II: Tumor Response

  2 months

Study Arms (6)

PART 1 - Cohort 1

EXPERIMENTAL

3-6 patients

Combination Product: PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 160 mg/m^2

PART 1 - Cohort 2

EXPERIMENTAL

3-6 patients

Combination Product: PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 320 mg/m^2

PART 1 - Cohort 3

EXPERIMENTAL

3-6 patients

Combination Product: PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 640 mg/m^2

PART 2 - Cohort 1

EXPERIMENTAL

Number of patients depend on Part 1

Combination Product: PIT: 75 J/cm^2 for superficial lesions or 150 J/cm for interstitial lesions and Drug RM-1929: 640mg/m^2

PART 2 - Cohort 2

EXPERIMENTAL

Number of patients depend on Part 1

Combination Product: PIT: 100 J/cm^2 for superficial lesions or 200 J/cm for interstitial lesions and Drug RM-1929: 640mg/m^2

PART 3

EXPERIMENTAL

Up to 30 patients

Combination Product: PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 640mg/m^2

Interventions

PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 160 mg/m^2 COMBINATION_PRODUCT

PART 1 - Cohort 1

PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 320 mg/m^2 COMBINATION_PRODUCT

PART 1 - Cohort 2

PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 640 mg/m^2 COMBINATION_PRODUCT

PART 1 - Cohort 3

PIT: 75 J/cm^2 for superficial lesions or 150 J/cm for interstitial lesions and Drug RM-1929: 640mg/m^2 COMBINATION_PRODUCT

PART 2 - Cohort 1

PIT: 100 J/cm^2 for superficial lesions or 200 J/cm for interstitial lesions and Drug RM-1929: 640mg/m^2 COMBINATION_PRODUCT

PART 2 - Cohort 2

PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 640mg/m^2 COMBINATION_PRODUCT

PART 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Rakuten Medical, Inc.: lead

Study Sites (7)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Centura Health Research Center

Denver, Colorado, 80210, United States

Location

Rush University Cancer Center

Chicago, Illinois, 60612, United States

Location

Virginia Piper Cancer Institute, part of Allina Health System

Minneapolis, Minnesota, 55407, United States

Location

University of Oklahoma Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Cognetti DM, Johnson JM, Curry JM, Kochuparambil ST, McDonald D, Mott F, Fidler MJ, Stenson K, Vasan NR, Razaq MA, Campana J, Ha P, Mann G, Ishida K, Garcia-Guzman M, Biel M, Gillenwater AM. Phase 1/2a, open-label, multicenter study of RM-1929 photoimmunotherapy in patients with locoregional, recurrent head and neck squamous cell carcinoma. Head Neck. 2021 Dec;43(12):3875-3887. doi: 10.1002/hed.26885. Epub 2021 Oct 9.

  PMID: 34626024 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2015
• First Posted: April 22, 2015
• Study Start: June 1, 2015
• Primary Completion: February 25, 2019
• Study Completion: February 25, 2019
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)