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

NCT02014909 | Completed Phase 1 DMC

• 1 other identifier: KTN3379-CL-001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 5

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicities for KTN3379 alone or in combination

  Continued assessment of safety

  Participants will be followed for the duration of treatment, an expected average of 3 cycles/9 weeks

Secondary Outcomes (1)

• Area Under the Concentration-Time Curve (AUC 0 through end of study)

  Prior to the initial dose on day 1 through duration of treatment, an expected average of 3 cycles/9 weeks

Study Arms (5)

KTN3379

EXPERIMENTAL

KTN3379

Biological: KTN3379

Part II, Arm A

EXPERIMENTAL

Combination of KTN3379 and cetuximab

Biological: KTN3379

Part II, Arm B

EXPERIMENTAL

Combination of KTN3379 and erlotinib

Biological: KTN3379

Part II, Arm C

EXPERIMENTAL

Combination of KTN3379 and vemurafenib

Biological: KTN3379

Part II, Arm D

EXPERIMENTAL

Combination of KTN3379 and trastuzumab

Biological: KTN3379

Interventions

KTN3379 BIOLOGICAL

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

KTN3379; Part II, Arm A; Part II, Arm B; Part II, Arm C; Part II, Arm D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celldex Therapeutics: lead

Study Sites (5)

Sarah Cannon Research Institute

Denver, Colorado, 80218, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06511, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 18, 2013
• Study Start: January 1, 2014
• Primary Completion: May 25, 2017
• Study Completion: June 5, 2017
• Last Updated: July 24, 2017

Record last verified: 2017-07

Locations

US (5)