A Window of Opportunity Study of KTN3379 in Surgically Resectable Head and Neck Cancer Patients

Completed · Phase 1

Conditions studied: Squamous Cell Carcinoma of the Head and Neck

In brief

The purpose of this study is to evaluate the activity and safety of KTN3379 in head and neck cancer patients and to explore downstream molecular pathways to identify tumor response and resistance mechanisms by evaluating various biomarkers before and after treatment.

Key facts

Study ID: NCT02473731
Run by: Celldex Therapeutics
People needed: 12
Starts: 2015-10-01
Expected to finish: 2016-10-10
Last updated by the study team: 2019-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically or cytologically confirmed primary, untreated SCCHN including variants. Patients must be candidates for surgical resection. Primary tumors of oral cavity, oropharynx, hypopharnyx or larynx are included.
Written informed consent and any locally required authorization (e.g., HIPAA in the USA) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of effective contraception from screening, and must agree to continue using such precautions for 60 days after the final dose of KTN3379. Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or those who are postmenopausal (defined as 12 months with no menses without an alternative medical cause)
Nonsterilized males who are sexually active with a female partner of child-bearing potential must, with their partner, use 2 acceptable methods of effective contraception from Day 1 through 60 days after receipt of the final dose of KTN3379.
Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
Adequate bone and marrow function as defined below:
Hemoglobin ≥ 10 g/dL
Absolute neutrophil count ≥ 1500/mm3
Platelet count ≥ 100,000/mm3
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ×ULN
Bilirubin ≤ 1.5 × ULN except for cases of documented or suspected Gilbert's disease, in which bilirubin must be ≤ 5 × ULN
Serum creatinine ≤ 1.5 g/dL
Normal PT or INR and aPTT

You may not qualify if…

Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment.
Immunosuppressive or systemic steroids medication within 7 days before the first dose of KTN3379 (inhaled and topical corticosteroids are permitted).
Another invasive malignancy within 2 years prior to enrollment except for localized prostate cancer, cervical carcinoma in situ, non-melanomatous carcinoma of the skin, or ductal carcinoma in situ of the breast that has/have been surgically cured
Major surgical procedure within 30 days prior to Day 1 or incomplete recovery from any prior surgery
Pregnancy or lactation
Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled or idiopathic hypotension, unstable angina pectoris, cardiac arrhythmia including atrial fibrillation, significant cardiac conduction abnormalities including prolongation of QTc interval or BBB, active peptic ulcer disease or gastritis, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent
Patients with a left ventricular cardiac ejection fraction < 50% as assessed by an echocardiogram or MUGA scan
Patients with prior primary treatment for head and neck cancer (e.g. chemoradiation or radiation alone).

Where it is running

UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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