Clinical trial · Interventional
A Phase 1 Dose Escalation Study of GC4419 in Combination With Chemoradiation for Squamous Cell Cancer of the Head & Neck
A Phase 1 Dose Escalation Study of GC4419 in Combination With Radiation and Chemotherapy for Squamous Cell Cancers of the Head and Neck.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety, tolerability, and the highest dose of GC4419 that can be given to patients with squamous cell cancer of the head and neck who are receiving standard radiation therapy and chemotherapy. This study will also evaluate GC4419 for the following: * Effect on the incidence and severity of radiation induced oral mucositis; * Effect on the response rate of squamous cell cancer of the head and neck who are receiving radiation therapy and chemotherapy; * Total concentrations of GC4419 that can be achieved in the blood; * Changes in proteins and genetics associated with oral mucositis; * Impact on delayed toxicities of radiation (dry mouth and reduced ability to fully open the mouth); * Observe changes in genetic and molecular markers of oral mucositis; * Observe the usage of extra health resources (e.g., unplanned ER visits, feeding tube use, etc.) of study patients; * Assess the overall quality of life in study patients with oral mucositis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma of the Oral Cavity | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma of the Oropharynx | Oropharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GC4419 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GC4419
- description
- Open label, dose escalation study of GC4419 administered in 14 doses, corresponding to the first 14 doses of radiation therapy. Each dose will be given intravenously over 60 minutes. The possible doses which may be tested are: 15mg, 30mg, 50mg, 75mg, 112mg, and 170mg.
- interventionNames
- Drug: GC4419
Primary outcomes (1)
- measure
- Frequency and Severity of Adverse Events Resulting from GC4419
- timeFrame
- 14 - 35 days
- description
- GC4419 will be evaluated to determine safety, tolerability, and the maximum tolerated dose of GC4419 that can be administered to patients with squamous cell cancer of the head and neck who are receiving concurrent radiation (50-70 Gy, administered daily x 5 \[M-F\], in 2.0-2.2 Gy fractions) and chemotherapy (cisplatin, 80-100mg/m2, q3 weeks or weekly cisplatin 30-40mg/m2 x 6 weeks). Patients will receive 14 - 35 doses of GC4419 in serially ascending cohorts for dose and duration, which correspond to the first doses of radiation, schedule dependent. Dose limiting toxicity will be evaluated through 24 hours following the last dose of GC4419.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically-confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN), defined as SCC of the oral cavity or oropharynx, that will be treated with standard cisplatin and Intensity-Modulated Radiation Therapy (IMRT) * Males or females aged 18 years or older * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Adequate bone marrow, liver and kidney function * Negative serum pregnancy test for females of childbearing potential * Properly obtained written informed consent Exclusion Criteria: * Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, salivary glands or unknown primary tumor * Metastatic disease (Stage IV C) * Prior chemotherapy for SCCHN and/or radiotherapy to the region of the study cancer or * Receiving any agent classified as an antioxidant * History of malignant tumors other than SCCHN within the last 5 years, except non-melanoma skin cancer or curatively excised in situ cervical carcinoma * Active infectious disease excluding oral candidiasis * Presence of oral mucositis at study entry * Chronic immunosuppression * Known history of HIV or active hepatitis B/C ) * Prior history of hearing impairment * Use of investigational agent within 30 days of study entry * Known allergies or intolerance to cisplatin and similar platinum-containing compounds * Requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure
References
Publications (0)
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