A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of KTN3379 in Adult Subjects With Advanced Tumors

Major Inclusion Criteria:

- 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

Major Exclusion Criteria:

- 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