None listed
Conditions
Interventions
Drug : Cetuximab (, Erbitux Injection) : Every 2weeks 500mg/m²
? Cetuximab 00 mg/m² dosing (IV) every 2 weeks (±2 days): at D1 and D15 in each 28 day cycle
Administration in IV (1 cycle=4 weeks, 2 dos
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Age = 19 years at the time of signing the informed consent form (ICF). ? Voluntary written informed consent obtained prior to the performance of any study-related assessments or procedures, with sufficient understanding of the study. ? Willingness and ability to comply with scheduled visits and protocol requirements. ? Histologically confirmed oral cavity cancer with TERT promoter mutation (-124C>T or -146C>T). ? Documented failure of prior platinum-based chemotherapy and/or immune checkpoint inhibitor therapy. ? No prior history of cetuximab or any other EGFR-targeted therapy. ? At least one measurable lesion according to RECIST version 1.1. ? ECOG performance status of 0–1. ? Women of childbearing potential (WOCBP) must have a negative urine (or serum) pregnancy test within 7 days prior to the first dose, and must agree to use effective contraception during treatment and for at least 90 days after the last dose. ? WOCBP are defined as all women after menarche who have not achieved postmenopausal status and have not undergone surgical sterilization (e.g., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy). ? Postmenopausal status is defined as =12 months of spontaneous amenorrhea without another medical cause. ? Women using oral contraceptives, intrauterine devices, or mechanical barrier methods are considered fertile. ? Men of reproductive potential must agree to use effective contraception during treatment and for at least 90 days after the last dose. ? Infertile males are defined as those with documented azoospermia on semen analysis. ? All participants must agree to use two contraceptive methods regardless of type: vasectomy or condom for male patients/partners, and tubal ligation, diaphragm, IUD, spermicide, or oral contraceptives for female patients/partners. ? Adequate organ function as demonstrated by: ? Hematology: ANC = 1.5 × 10?/L; Platelets = 100 × 10?/L; Hemoglobin = 9.0 g/dL ? Renal: Serum creatinine = 1.5 × ULN, or estimated GFR (by CKD-EPI) = 45 mL/min/1.73 m² ? Hepatic: Total bilirubin = 1.5 × ULN (= 3 × ULN if Gilbert’s syndrome); AST and ALT < 3 × ULN (< 5 × ULN if liver metastases are present)
Exclusion criteria
Exclusion criteria: ? Major surgery within 4 weeks prior to first dose (per investigator’s judgment), or planned surgery within 6 months after screening. ? History of another malignancy within the past 2 years, except: A. Effectively treated non-melanoma skin cancer B. Effectively treated carcinoma in situ of the cervix C. Effectively treated ductal carcinoma in situ of the breast D. Other malignancies considered cured by local therapy alone ? Receipt of systemic anticancer therapy or investigational drug within 21 days or 5 half-lives (whichever is shorter) prior to first dose. ? Prior history of EGFR-targeted therapy. ? More than two prior lines of systemic anticancer therapy. ? Any history or comorbidity that, in the investigator’s judgment, would interfere with participation or with evaluation of safety/efficacy. ? Clinically significant cardiovascular disease, including uncontrolled hypertension, congestive heart failure (NYHA class = III), unstable angina, uncontrolled arrhythmias, or myocardial infarction within 6 months. ? Clinically significant ECG abnormalities (per investigator’s judgment), such as complete left bundle branch block or third-degree heart block. ? Ejection fraction (EF) < 50% or below institutional lower limit of normal. Patients may be eligible if, based on clinical judgment, there is no evidence of significant cardiac deterioration since an echocardiogram performed within 6 months. ? Pregnant or breastfeeding women, or women planning to become pregnant during the study or within 90 days after last dose. ? History or presence of uncontrolled or symptomatic brain metastases, leptomeningeal disease, or dural metastases. Patients may be eligible if local therapy is complete, disease is stable, and corticosteroid dose is stable or tapering for =1 week. Newly diagnosed asymptomatic brain metastases may be eligible if not requiring immediate CNS therapy (per investigator’s judgment). ? Active infection with hepatitis B, hepatitis C, or HIV that is deemed clinically significant by the investigator. ? Known hypersensitivity to cetuximab or any excipient of the study drug. ? History of alcohol or drug abuse that, in the investigator’s judgment, could interfere with trial participation. ? Patients anticipated to be non-compliant with the protocol or unable to complete the study as scheduled (e.g., due to chronic substance abuse or other conditions deemed unreliable by the investigator).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Safety;Quality of life | — |
Countries
Korea, Republic of
Contacts
Public ContactBhumsuk Keam
Seoul National University Hospital
Outcome results
None listed