A Phase 1/2 interventional study of PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 160 mg/m^2 and PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 320 mg/m^2 in Recurrent Head and Neck Cancer, sponsored by Rakuten Medical, Inc.. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-26.
Sponsored by Rakuten Medical, Inc. · Phase 1/2, Interventional, and Treatment
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.
Photoimmunotherapy (PIT) is a new cancer targeted technology invented at the National Cancer Institute, USA. This clinical study evaluates the treatment of the experimental drug RM-1929 with Photoimmunotherapy (PIT).
The experimental drug, RM-1929, is a parental formulation consisting of a chemical conjugate of the dye IR700 with the FDA approved antibody, Erbitux® (Cetuximab), that targets EGFR receptors (EGFR is a cancer expressed protein, a cancer antigen). EGFR is highly expressed in squamous cell carcinomas of the head and neck (HNSCC). It is expected that systemic administration of RM-1929 will lead to tumor accumulation and binding to EGFR expressed at cancer cells. It is expected that treatment with RM-1929 and Photoimmunotherapy can lead to the selective destruction of the HNSCC cancer cells and provide an effective therapy to manage the disease.
The treatment using RM-1929 with Photoimmunotherapy requires two steps:
(i) the administration by infusion of the drug RM-1929 targeting the cancer protein EGFR
AND
(ii) the illumination of the tumor with red light (690 nm) using sufficient energy to activate the drug and induce cancer cell killing.
Light illumination is applied at 24 h post drug infusion to enable sufficient time for the drug to distribute in the tumor after administration. Cell killing occurs only at cancer cells expressing the protein EGFR that is bound to the drug RM-1929. The requirement of binding of the drug to EGFR of cancer cells enables the selective destruction of cancer cells with minimum damage of healthy tissue surrounding the tumor cells. Preclinical pharmacology demonstrated that light-induced activation of RM-1929 elicits rapid tumor destruction of human cancer xenografts implanted in mice and that the treatment is cancer specific.
The Part 1 study has been completed and consisted of a single cycle 3+3 dose escalation study of RM-1929 to determine the safety of the treatment and the maximal feasible dose of RM-1929. From the part 1 of this study, the maximal feasible dose for treatment with RM-1929 was selected. The currently ongoing Part 2 of the clinical study is evaluating the safety and anti-cancer activity of up to 4 repeat treatment cycles of Photoimmunotherapy with RM-1929.
2,403 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.
This study's enrollment of 40 is below the median of 47 across 1,791 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Rakuten Medical, Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must meet the following criteria to be eligible for study participation:
Exclusion Criteria:
Patients with any of the following will be excluded from participation in the study:
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
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
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
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
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
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
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
Time frame: 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
Time frame: 1 month
Part I: Photosafety (sunburn) Testing
Determination of skin Minimal Erythema Dose (MED) following infusion of RM-1929
Time frame: 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
Time frame: 1 month
Part II: Safety with repeat dosing
Safety parameters associated with repeat dosing
Time frame: 2 years or until death
Part I: Tumor response
Document tumor response using response assessment in solid tumors version 1.1 (RECIST 1.1), including additional assessment of target lesion volumetrics
Time frame: 2 months
Part 1: Tumor reduction/necrosis
Document tumor reduction/necrosis using Choi criteria
Time frame: 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)
Time frame: 1 month
Part I: Immunogenic response to RM-1929
To assess antibodies to RM-1929 or cetuximab
Time frame: 2 month
Part II: Tumor Response
Assessed using RECIST 1.1
Time frame: 2 months
Part II: Tumor Reduction
Evaluation by CT scans, clinical measurement, photographs, biopsies, symptom relief and ECOG performance
Time frame: 2 months
Part II: Immunogenic response to RM-1929
To assess antibodies to RM-1929 or cetuximab
Time frame: 2 months
Plan to share: No
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rakuten Medical, Inc.