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Also known as Dusquetide, SGX945
SGX942 · 3 trials · 3 indications
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.
The number of oral ulcers were counted at baseline and each visit during the treatment period.
The number of genital ulcers will be counted at baseline and each visit during the treatment period.
| Arm | Type | Description |
|---|---|---|
| SGX942 | EXPERIMENTAL | Patients are randomized 1:1 active/placebo. |
| Placebo | PLACEBO_COMPARATOR | Patients are randomized 1:1 active/placebo. |
| SGX945 | EXPERIMENTAL | This is an open-label study and all participants will receive SGX945. |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Dusquetide | DRUG | 1.5 mg/mL dusquetide administered as a 4 minute IV infusion, twice per week for 4 weeks |
Inclusion Criteria: * 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 radiat...
SGX942 is an investigational small molecule being studied for oral mucositis in patients with squamous cell carcinoma of the oral cavity and oropharynx who are receiving chemoradiation therapy for head and neck cancer. It is being developed by Soligenix, Inc. and is currently in clinical development.
SGX942 is being developed by Soligenix, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug for the treatment of oral mucositis in patients with head and neck cancer.
SGX942 has completed a Phase 2 clinical trial and a Phase 3 clinical trial. The drug is investigational and remains in clinical development. It has not been approved by the FDA for any use.
SGX942 has been studied in two completed clinical trials. NCT02013050 was a Phase 2 dose-escalating study in 111 patients with oral mucositis in the United States. NCT03237325 was a Phase 3 study in 266 patients with squamous cell carcinoma of the oral cavity and oropharynx and oral mucositis, conducted in the United States, Belgium, France, Spain, and the United Kingdom.
SGX942 is the drug name used in clinical trials for this investigational therapy. No alternative names have been reported for this drug in the clinical trial information available.