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).
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
Interventions
Drug | Synonyms | Arms |
---|
KTN3379 | | KTN3379 |
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
Name | Type | Description | Interventions |
---|
KTN3379 | Experimental | KTN3379 | |
Part II, Arm A | Experimental | Combination of KTN3379 and cetuximab | |
Part II, Arm B | Experimental | Combination of KTN3379 and erlotinib | |
Part II, Arm C | Experimental | Combination of KTN3379 and vemurafenib | |
Part II, Arm D | Experimental | Combination of KTN3379 and trastuzumab | |
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 24, 2017