Gland and Hormone Related Diseases

All Conditions

Neoplasms

Thyroid Diseases

Thyroid Neoplasms

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Immunoglobulins

Vemurafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

Vemurafenib 960 mg po bid KTN3379 1000 mg IV q2weeks

KTN3379

vemurafenib

This is a patient pilot study testing the hypothesis that vemurafenib with the addition of KTN3379 can restore iodine incorporation in BRAF mutant (MUT), radioiodine-refractory (RAIR) thyroid cancer patients.

This is a patient pilot study testing the hypothesis that vemurafenib with the addition of KTN3379 can restore iodine incorporation in BRAF mutant (MUT), radioiodine-refractory (RAIR) thyroid cancer patients. Eligible patients with BRAF MUT, RAIR thyroid cancer will undergo human recombinant TSH (rhTSH or Thyrogen)-stimulated 124I PET/CT lesional dosimetry to quantify the baseline RAI avidity of index metastatic lesion(s). Patients will then receive vemurafenib followed by the addition of KTN3379 after which a second Thyrogen-stimulated 124I PET/CT lesional dosimetry will be performed. For patients whose tumor(s) demonstrate sufficient iodine incorporation warranting 131I therapy, Thyrogen-stimulated standard dosimetry will be performed and therapeutic 131I will be administered concurrently with vemurafenib and KTN3379. Subsequent to discontinuation of vemurafenib, tumor assessments will be conducted with serial radiologic scan(s) and thyroglobulins (scans will be performed at baseline, before 131I, 3 months (+/- 1 month) following 131I, and 6 months after 131I).

Enhancing Radioiodine Incorporation Into BRAF Mutant Thyroid Cancers With the Combination of Vemurafenib and KTN3379

Enhancing Radioiodine (RAI) Incorporation Into BRAF Mutant, RAI Refractory Thyroid Cancers With the Combination of BRAF Inhibitor Vemurafenib and Anti-ErbB3 Antibody KTN3379: A Pilot Study With a Phase 1 Run-in

Memorial Sloan Kettering Cancer Center

Celldex Therapeutics

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Treatment with KTN3379 in HPV positive head and neck cancer patients

Treatment with KTN3379 in HPV negative head and neck cancer patients

The purpose of this study is to evaluate the activity and safety of KTN3379 in head and neck cancer patients and to explore downstream molecular pathways to identify tumor response and resistance mechanisms by evaluating various biomarkers before and after treatment.

This is an open-label study in patients with squamous cell carcinoma of the head and neck (SCCHN) scheduled for surgery. Two cohorts of SCCHN patients, HPV negative and HPV positive, will be treated with KTN3379 to evaluate effects on ErbB3 phosphorylation and other biomarkers in tumor tissue. The KTN3379 treatment duration is within the expected window of time that elapses from initial patient evaluation by a surgeon to performance of surgery. Paired preoperative and postoperative tumor specimen analyses allow evaluation of proliferation, ErbB3 related biomarkers, pErbB3 modulation and pharmacodynamic changes in downstream molecular pathways.

A Window of Opportunity Study of KTN3379 in Surgically Resectable Head and Neck Cancer Patients

Adverse events (AEs), serious adverse events (SAEs), laboratory evaluations, radiological assessments, vital signs, electrocardiograms (ECGs), and physical examinations.

Ki67 proliferative index in tumor tissue before and after treatment

RECIST 1.1 measurements before and after treatment

Peak plasma concentrations of KTN3379 Trough plasma concentrations of KTN3379

Measurement of anti KTN3379 antibodies in blood

Trastuzumab

Antibodies, Monoclonal

Cetuximab

Erlotinib Hydrochloride

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

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).

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Enhancing Radioiodine Incorporation Into BRAF Mutant Thyroid Cancers With the Combination of Vemurafenib and KTN3379	NCT02456701	Thyroid Cancer	KTN3379 vemurafenib	18 Years -	Celldex Therapeutics
Enhancing Radioiodine Incorporation Into BRAF Mutant Thyroid Cancers With the Combination of Vemurafenib and KTN3379	NCT02456701	Thyroid Cancer	KTN3379 vemurafenib	18 Years -	Celldex Therapeutics
A Window of Opportunity Study of KTN3379 in Surgically Resectable Head and Neck Cancer Patients	NCT02473731	Squamous Cell C...	KTN3379	18 Years -	Celldex Therapeutics
Enhancing Radioiodine Incorporation Into BRAF Mutant Thyroid Cancers With the Combination of Vemurafenib and KTN3379	NCT02456701	Thyroid Cancer	KTN3379 vemurafenib	18 Years -	Celldex Therapeutics
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of KTN3379 in Adult Subjects With Advanced Tumors	NCT02014909	Advanced Cancer	KTN3379	18 Years -	Celldex Therapeutics

Spots Global Cancer Trial Database for cdx3379

Every month we try and update this database with for cdx3379 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cdx3379

Every month we try and update this database with for cdx3379 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cdx3379 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.