Clinical Trials /

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

NCT02014909

Description:

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).

Related Conditions:
  • Breast Carcinoma
  • Colorectal Carcinoma
  • Gastric Carcinoma
  • Head and Neck Carcinoma
  • Malignant Solid Tumor
  • Melanoma
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: KTN3379-CL-001
  • NCT ID: NCT02014909

Conditions

  • Advanced Cancer

Interventions

DrugSynonymsArms
KTN3379KTN3379

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
KTN3379ExperimentalKTN3379
  • KTN3379
Part II, Arm AExperimentalCombination of KTN3379 and cetuximab
  • KTN3379
Part II, Arm BExperimentalCombination of KTN3379 and erlotinib
  • KTN3379
Part II, Arm CExperimentalCombination of KTN3379 and vemurafenib
  • KTN3379
Part II, Arm DExperimentalCombination of KTN3379 and trastuzumab
  • KTN3379

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:Continued assessment of safety

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Celldex Therapeutics

Trial Keywords

  • KTN3379
  • Advanced cancer
  • Phase 1
  • Monoclonal antibody
  • Safety and pharmacokinetics
  • CDX3379

Last Updated

July 21, 2017