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

Advanced Cancer Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT02014909
• Other study ID #: KTN3379-CL-001
• Status: Completed
• Phase: Phase 1
• First received: December 4, 2013
• Last updated: July 21, 2017
• Start date: January 2014
• Est. completion date: June 5, 2017

Study information

• Verified date: July 2017
• Source: Celldex Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 5, 2017
• Est. primary completion date: May 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Sarah Cannon Research Institute	Denver	Colorado
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Yale Cancer Center	New Haven	Connecticut
United States	University of Pennsylvania Perelman School of Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Celldex Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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