DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer

NCT03237325 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: IDR-OM-02
• Study Type: interventional
• Target: 266
• Locations: 5 countries
• Sites: 53

Brief Summary

To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis in patients receiving chemoradiation treatment for the treatment of head and neck cancer

Conditions

Squamous Cell Carcinoma of the Oral Cavity and Oropharynx; Oral Mucositis

Keywords

OM; Head and Neck Cancer; SGX942; Dusquetide; Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Duration of Severe Oral Mucositis (SOM)

  To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis (SOM; defined as World Health Organization \[WHO\] Grade ≥3). Duration of SOM is defined as the number of days from the onset of SOM until resolution of SOM. OM is evaluated using the published WHO OM grading scale that uses a scale of 0 to 4, with SOM defined as a score ≥3.

  approx. 13 weeks

Study Arms (2)

SGX942

EXPERIMENTAL

Patients are randomized 1:1 active/placebo.

Drug: SGX942

Placebo

PLACEBO COMPARATOR

Patients are randomized 1:1 active/placebo.

Drug: Placebo

Interventions

SGX942 DRUG

1.5 mg/mL SGX942 administered as a 4 minute IV infusion, twice per week starting within 3 days after initiating radiation therapy and continuing through 2 weeks after radiation therapy ends.

Also known as: Dusquetide

SGX942

Placebo DRUG

Placebo is 0.9% sodium chloride (normal saline). The treatment preparation, frequency and duration of therapy are identical to that of the active drug.

Placebo

Eligibility Criteria

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

You may qualify if:

• Biopsy-proven squamous cell carcinoma of the oral cavity or oropharynx without distant organ metastases
• Scheduled to receive cisplatin chemotherapy of 80-100 mg/m²
• Scheduled to receive a continuous course of fractionated, conventional external beam with a cumulative radiation dose between 55 and 72 Gy at each site

You may not qualify if:

• Current mucositis
• Current, clinically significant, active infection that in the opinion of the Investigator would make them an unfit participant in the trial
• Planned to receive Erbitux™ (Cetuximab) or similar targeted therapy between Baseline and 6 weeks post-RT
• Prior radiation to the head and neck
• Chemotherapy treatment within the previous 12 months
• Tumors of the lips, sinuses, salivary glands, nasopharynx, hypopharynx, or larynx
• Evidence of significant renal, hepatic, hematologic, or immunologic disease determined by any one of the following: Estimated creatinine clearance \<30 mL/min; ALT or AST level greater than 10-fold the upper limit of normal or total bilirubin greater than 3-fold the upper limit of normal; Manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy; Thrombocytopenia; or CD4+ T cell count below 200 cells per μL
• Evidence of immediate life-threatening disease or a life expectancy of less than 3 months
• Women who are pregnant or breast-feeding
• Participation in any study involving administration of an investigational agent within 30 days of randomization into this study

Sponsors & Collaborators

• Soligenix: lead

Study Sites (53)

Arizona Clinical Research Center

Tucson, Arizona, 85715, United States

Location

Loma Linda University Health

Loma Linda, California, 92354, United States

Location

Pomona Valley Hospital Medical Center

Pomona, California, 91767, United States

Location

Cancer Specialists of North Florida

Jacksonville, Florida, 32256, United States

Location

Lakes Research

Miami Lakes, Florida, 33014, United States

Location

University Cancer & Blood

Athens, Georgia, 30607, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Memorial Health

Savannah, Georgia, 31404, United States

Location

University of Illinois Cancer Center

Chicago, Illinois, 60612, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Des Moines Oncology Research Association

Des Moines, Iowa, 50309, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Ashland Bellefonte Cancer Center

Ashland, Kentucky, 41101, United States

Location

Willis Knighton Cancer Center

Shreveport, Louisiana, 71103, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Minnesota Oncology

Saint Louis Park, Minnesota, 55416, United States

Location

University of Missouri-Ellis Fischel Cancer Center

Columbia, Missouri, 65203, United States

Location

Great Falls Clinic

Great Falls, Montana, 59405, United States

Location

CHI Health St. Francis

Grand Island, Nebraska, 68803, United States

Location

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, 89052, United States

Location

Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Hackensack Meridian Health

Neptune City, New Jersey, 07753, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Summa Health Cancer Research

Akron, Ohio, 44304, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Mercy Clinic Oncology and Hematology

Oklahoma City, Oklahoma, 73120, United States

Location

Oklahoma Cancer Specialists

Tulsa, Oklahoma, 74146, United States

Location

Charleston Cancer Center

Charleston, South Carolina, 29406, United States

Location

Spartanburg Regional-Gibbs Cancer Center

Spartanburg, South Carolina, 29303, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Providence Regional Cancer Partnership

Everett, Washington, 98201, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium

Location

Centre Hospitalier Jolimont

La Louvière, Belgium

Location

Centre Hospitalier Universitaire de Mons

Mons, Belgium

Location

CFRO Clinique Pasteur

Brest, France

Location

Institut Andrée Dutreix

Dunkirk, France

Location

Clinique Victor Hugo

Le Mans, France

Location

Hôpital de la Croix Rousse

Lyon, France

Location

CROM-Osny

Osny, France

Location

Centre Hospitalier Privé St Grégoire

Saint-Grégoire, France

Location

Institut Català d'Oncologia Badalona

Badalona, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Institut Català d'Oncologia Girona

Girona, Spain

Location

Hospital Universitario Severo Ochoa

Leganés, Spain

Location

Hospital Regional Universitario de Málaga

Málaga, Spain

Location

Hospital Son Llàtzer

Palma de Mallorca, Spain

Location

Hospital Universitari Son Espases

Palma de Mallorca, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

Location

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Location

Edinburgh Cancer Centre

Edinburgh, United Kingdom

Location

Guy's Hospital

London, United Kingdom

Location

Weston Park Hospital

Sheffield, United Kingdom

Location

Related Publications (3)

• North JR, Takenaka S, Rozek A, Kielczewska A, Opal S, Morici LA, Finlay BB, Schaber CJ, Straube R, Donini O. A novel approach for emerging and antibiotic resistant infections: Innate defense regulators as an agnostic therapy. J Biotechnol. 2016 May 20;226:24-34. doi: 10.1016/j.jbiotec.2016.03.032. Epub 2016 Mar 23.

  PMID: 27015977 BACKGROUND

• Kudrimoti M, Curtis A, Azawi S, Worden F, Katz S, Adkins D, Bonomi M, Elder J, Sonis ST, Straube R, Donini O. Dusquetide: A novel innate defense regulator demonstrating a significant and consistent reduction in the duration of oral mucositis in preclinical data and a randomized, placebo-controlled phase 2a clinical study. J Biotechnol. 2016 Dec 10;239:115-125. doi: 10.1016/j.jbiotec.2016.10.010. Epub 2016 Oct 13.

  PMID: 27746305 BACKGROUND

• Kudrimoti M, Curtis A, Azawi S, Worden F, Katz S, Adkins D, Bonomi M, Scott Z, Elder J, Sonis ST, Straube R, Donini O. Dusquetide: Reduction in oral mucositis associated with enduring ancillary benefits in tumor resolution and decreased mortality in head and neck cancer patients. Biotechnol Rep (Amst). 2017 May 17;15:24-26. doi: 10.1016/j.btre.2017.05.002. eCollection 2017 Sep.

  PMID: 28649557 BACKGROUND

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Stomatitis; Head and Neck Neoplasms; Carcinoma, Squamous Cell

Interventions

dusquetide

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases; Neoplasms, Squamous Cell

Results Point of Contact

• Title: Richard Straube, MD/Chief Medical Officer
• Organization: Soligenix, Inc.

rstraube@soligenix.com

609-538-8200

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 2, 2017
• Study Start: December 4, 2017
• Primary Completion: June 24, 2020
• Study Completion: June 24, 2021
• Last Updated: November 8, 2022
• Results First Posted: August 29, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (32); BE (3); FR (6); ES (8); GB (4)