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

NCT ID: NCT02014909

Last Updated: 2017-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-06-05

Brief Summary

Part I will evaluate the pharmacokinetic profile and safety of KTN3379 over several doses with the objective of defining a Phase 2 dose in patients with advanced malignancies. Part II will evaluate the pharmacokinetic profile and safety of KTN3379 in combination with other targeted agents and obtain preliminary evidence of anti tumor activity in specific types of cancer. Patients will continue receiving KTN3379 alone or in combination until disease progression or toxicity that necessitates discontinuation (whichever comes first).

Conditions

Advanced Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KTN3379

KTN3379

Group Type: EXPERIMENTAL

KTN3379

Intervention Type: BIOLOGICAL

Single agent KTN3379 or in combination administered until unacceptable toxicity or progressive disease

Part II, Arm A

Combination of KTN3379 and cetuximab

Group Type: EXPERIMENTAL

KTN3379

Intervention Type: BIOLOGICAL

Single agent KTN3379 or in combination administered until unacceptable toxicity or progressive disease

Part II, Arm B

Combination of KTN3379 and erlotinib

Group Type: EXPERIMENTAL

KTN3379

Intervention Type: BIOLOGICAL

Single agent KTN3379 or in combination administered until unacceptable toxicity or progressive disease

Part II, Arm C

Combination of KTN3379 and vemurafenib

Group Type: EXPERIMENTAL

KTN3379

Intervention Type: BIOLOGICAL

Single agent KTN3379 or in combination administered until unacceptable toxicity or progressive disease

Part II, Arm D

Combination of KTN3379 and trastuzumab

Group Type: EXPERIMENTAL

KTN3379

Intervention Type: BIOLOGICAL

Single agent KTN3379 or in combination administered until unacceptable toxicity or progressive disease

Interventions

KTN3379

Single agent KTN3379 or in combination administered until unacceptable toxicity or progressive disease

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celldex Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sarah Cannon Research Institute

Denver, Colorado, United States

Yale Cancer Center

New Haven, Connecticut, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

KTN3379-CL-001

Identifier Type: -

Identifier Source: org_study_id