Study of RM-1929 and Photoimmunotherapy in Patients With Recurrent Head and Neck Cancer
Public ClinicalTrials.gov record NCT02422979. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2a Multicenter, Open-Label, Dose-Escalation, Combination Study of RM-1929 and Photoimmunotherapy in Patients With Recurrent Head and Neck Cancer, Who in the Opinion of Their Physician, Cannot Be Satisfactorily Treated With Surgery, Radiation or Platinum Chemotherapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02422979
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 40 participants
Conditions and interventions
Conditions
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
- 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
- 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
- PIT: 75 J/cm^2 for superficial lesions or 150 J/cm for interstitial lesions and Drug RM-1929: 640mg/m^2 Combination Product
- PIT: 100 J/cm^2 for superficial lesions or 200 J/cm for interstitial lesions and Drug RM-1929: 640mg/m^2 Combination Product
- PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 640mg/m^2 Combination Product
Combination Product
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2015
- Primary completion
- Feb 24, 2019
- Completion
- Feb 24, 2019
- Last update posted
- Feb 25, 2020
2015 – 2019
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | — |
| Centura Health Research Center | Denver | Colorado | 80210 | — |
| Rush University Cancer Center | Chicago | Illinois | 60612 | — |
| Virginia Piper Cancer Institute, part of Allina Health System | Minneapolis | Minnesota | 55407 | — |
| University of Oklahoma Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02422979, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 25, 2020 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02422979 live on ClinicalTrials.gov.