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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02014909
Recruitment Status : Completed
First Posted : December 18, 2013
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Celldex Therapeutics

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).

Condition or disease Intervention/treatment Phase
Advanced Cancer Biological: KTN3379 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Part I and Part II A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KTN3379 in Adult Subjects With Advanced Tumors Alone or With Chemotherapy
Study Start Date : January 2014
Actual Primary Completion Date : May 25, 2017
Actual Study Completion Date : June 5, 2017

Arm Intervention/treatment
Experimental: KTN3379
KTN3379
Biological: KTN3379
Single agent KTN3379 or in combination administered until unacceptable toxicity or progressive disease

Experimental: Part II, Arm A
Combination of KTN3379 and cetuximab
Biological: KTN3379
Single agent KTN3379 or in combination administered until unacceptable toxicity or progressive disease

Experimental: Part II, Arm B
Combination of KTN3379 and erlotinib
Biological: KTN3379
Single agent KTN3379 or in combination administered until unacceptable toxicity or progressive disease

Experimental: Part II, Arm C
Combination of KTN3379 and vemurafenib
Biological: KTN3379
Single agent KTN3379 or in combination administered until unacceptable toxicity or progressive disease

Experimental: Part II, Arm D
Combination of KTN3379 and trastuzumab
Biological: KTN3379
Single agent KTN3379 or in combination administered until unacceptable toxicity or progressive disease




Primary Outcome Measures :
  1. Dose limiting toxicities for KTN3379 alone or in combination [ Time Frame: Participants will be followed for the duration of treatment, an expected average of 3 cycles/9 weeks ]
    Continued assessment of safety


Secondary Outcome Measures :
  1. Area Under the Concentration-Time Curve (AUC 0 through end of study) [ Time Frame: Prior to the initial dose on day 1 through duration of treatment, an expected average of 3 cycles/9 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02014909


Locations
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United States, Colorado
Sarah Cannon Research Institute
Denver, Colorado, United States, 80218
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06511
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Pennsylvania
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Celldex Therapeutics
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Responsible Party: Celldex Therapeutics
ClinicalTrials.gov Identifier: NCT02014909    
Other Study ID Numbers: KTN3379-CL-001
First Posted: December 18, 2013    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017
Keywords provided by Celldex Therapeutics:
KTN3379
Advanced cancer
Phase 1
Monoclonal antibody
Safety and pharmacokinetics
CDX3379