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

• ClinicalTrials.gov Identifier: NCT02014909
• Recruitment Status: Completed
• First Posted: December 18, 2013
• Last Update Posted: July 24, 2017
• Sponsor: Celldex Therapeutics
• Information provided by (Responsible Party): Celldex Therapeutics

Tracking Information

• First Submitted Date: December 4, 2013
• First Posted Date: December 18, 2013
• Last Update Posted Date: July 24, 2017
• Study Start Date: January 2014
• Actual Primary Completion Date: May 25, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

• Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Advanced Cancer

Intervention

Biological: KTN3379

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

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 29, 2016): 64
• Original Estimated Enrollment (submitted: December 12, 2013): 24
• Actual Study Completion Date: June 5, 2017
• Actual Primary Completion Date: May 25, 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02014909
• Other Study ID Numbers: KTN3379-CL-001
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Celldex Therapeutics
• Original Responsible Party: Kolltan Pharmaceuticals, Inc.
• Current Study Sponsor: Celldex Therapeutics
• Original Study Sponsor: Kolltan Pharmaceuticals, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Celldex Therapeutics
• Verification Date: July 2017