Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Celldex Therapeutics
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Part I Histologically- or cytologically-confirmed advanced solid tumors that are refractory to standard therapy or for which no standard therapy exist. Part II Arm A have head and neck cancer or K-Ras wild type EGFR expressing colon cancer, Arm B, have non small cell lung cancer, Arm C, have BRAF V600E mutated melanoma and Arm D have HER2 positive breast or gastric cancer that has progressed following one or more treatments for advanced or metastatic disease.
Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
Adequate organ function as defined below:
* Hemoglobin ≥ 9 g/dL
* Absolute neutrophil count ≥ 1500/mm3
* Platelet count ≥ 100,000/mm3
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × institutional upper limit of normal (ULN) for cases involving liver metastasis and ≤ 2.5 ×ULN for all other cases
* 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
Measurable disease by RECIST
Females must be surgically sterile, one year post menopausal or negative results for a pregnancy test performed at Screening and agree to use two methods of contraception; Males who have not had a vasectomy must agree to two methods of contraception
You may not be if
Receipt of anticancer therapy:
* within 3 weeks prior to the first dose of KTN3379, or
* within 6 weeks or 7 half lives prior to the first dose of KTN3379 in the case of anticancer therapy involving MAbs, or
* within 2 weeks prior to the first dose of KTN3379 in the case of palliative radiation therapy.
Symptomatic or untreated central nervous system metastases requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids; if treated, subject must be asymptomatic for 3 months prior to study entry
Subjects who are known to have a history of or active human immunodeficiency virus (HIV) or active hepatitis B and/or C
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, active peptic ulcer disease or gastritis, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
Subjects with a left ventricular cardiac ejection fraction \< 50% as assessed by an echocardiogram or MUGA scan
Clareo Health | A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of KTN3379 in Adult Subjects With Advanced Tumors
