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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

Tracking Information
First Submitted Date  ICMJE December 4, 2013
First Posted Date  ICMJE December 18, 2013
Last Update Posted Date July 24, 2017
Study Start Date  ICMJE January 2014
Actual Primary Completion Date May 25, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2014)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 12, 2013)
Maximum tolerated dose and dose limiting toxicities for Phase 2 dose and schedule [ Time Frame: Participants will be followed for the duration of treatment, an expected average of 3 cycles/9 weeks ]
Continued assessment of safety
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2013)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of KTN3379 in Adult Subjects With Advanced Tumors
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cancer
Intervention  ICMJE Biological: KTN3379
Single agent KTN3379 or in combination administered until unacceptable toxicity or progressive disease
Study Arms  ICMJE
  • Experimental: KTN3379
    KTN3379
    Intervention: Biological: KTN3379
  • Experimental: Part II, Arm A
    Combination of KTN3379 and cetuximab
    Intervention: Biological: KTN3379
  • Experimental: Part II, Arm B
    Combination of KTN3379 and erlotinib
    Intervention: Biological: KTN3379
  • Experimental: Part II, Arm C
    Combination of KTN3379 and vemurafenib
    Intervention: Biological: KTN3379
  • Experimental: Part II, Arm D
    Combination of KTN3379 and trastuzumab
    Intervention: Biological: KTN3379
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2016)
64
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2013)
24
Actual Study Completion Date  ICMJE June 5, 2017
Actual Primary Completion Date May 25, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02014909
Other Study ID Numbers  ICMJE KTN3379-CL-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Celldex Therapeutics
Original Responsible Party Kolltan Pharmaceuticals, Inc.
Current Study Sponsor  ICMJE Celldex Therapeutics
Original Study Sponsor  ICMJE Kolltan Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Celldex Therapeutics
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP