Tesevatinib

Generic Name: Tesevatinib

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₂₅Cl_₂FN_₄O_₂

CAS Number: 781613-23-8

Unique Ingredient Identifier: F6XM2TN5A1

Background: Tesevatinib has been used in trials studying the treatment of Cancer, Stomach Cancer, Brain Metastases, Esophageal Cancer, and Leptomeningeal Metastases, among others.

Tesevatinib is a potent inhibitor of multiple RTKs implicated in driving tumor cell proliferation and tumor vascularization (blood vessel formation). Tesevatinib inhibits the EGF, HER2, and VEGF RTKs, each of which is a target of currently approved cancer therapies. In addition, tesevatinib inhibits EphB4, an RTK that is highly expressed in many human tumors and plays a role in promoting angiogenesis. In a broad array of preclinical tumor models including breast, lung, colon and prostate cancer, XL647 demonstrated potent inhibition of tumor growth and causes tumor regression. In cell culture models, tesevatinib retains significant potency against mutant EGFRs that are resistant to current EGFR inhibitors.

Clinical Trials

Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD

Phase 2

Completed

Conditions: Autosomal Dominant Polycystic Kidney
ADPKD

Interventions: Drug: Placebo
Drug: Tesevatinib

First Posted Date: 2017-06-29

Last Posted Date: 2023-02-06

Lead Sponsor: Kadmon, a Sanofi Company

Target Recruit Count: 80

Registration Number: NCT03203642

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
California Institute for Renal Research, La Mesa, California, United States
🇺🇸
University of Maryland, Baltimore, Maryland, United States

and more 16 locations

A Safety, Pharmacokinetic, Single Ascending Dose Study of Tesevatinib in Pediatric Subjects With Autosomal Recessive Polycystic Kidney Disease (ARPKD)

Phase 1

Completed

Conditions: Polycystic Kidney, Autosomal Recessive

Interventions: Drug: Tesevatinib

First Posted Date: 2017-03-30

Last Posted Date: 2022-05-11

Lead Sponsor: Kadmon Corporation, LLC

Target Recruit Count: 10

Registration Number: NCT03096080

Locations: 🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
🇺🇸
Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States

Study of Tesevatinib Monotherapy in Patients With Recurrent Glioblastoma

Phase 2

Completed

Conditions: Brain Tumor
Recurrent Glioblastoma
Glioblastoma

Interventions: Drug: Tesevatinib

First Posted Date: 2016-07-26

Last Posted Date: 2021-09-22

Lead Sponsor: Kadmon Corporation, LLC

Target Recruit Count: 40

Registration Number: NCT02844439

Locations: 🇺🇸
City of Hope, Duarte, California, United States
🇺🇸
Center for Neurosciences, Tucson, Arizona, United States
🇺🇸
Henry Ford Hospital, Detroit, Michigan, United States

and more 8 locations

Phase 2 Study of Study of Tesevatinib in Subjects With NSCLC and Brain or Leptomeningeal Metastases

Phase 2

Completed

Conditions: Non-Small Cell Lung Cancer
Leptomeningeal Metastases
Brain Metastases

Interventions: Drug: Tesevatinib

First Posted Date: 2015-11-26

Last Posted Date: 2022-03-16

Lead Sponsor: Kadmon Corporation, LLC

Target Recruit Count: 36

Registration Number: NCT02616393

Locations: 🇺🇸
Beverly Hills Cancer Center, Beverly Hills, California, United States
🇺🇸
USC Norris Oncology/Hematology Newport Beach, Newport Beach, California, United States
🇺🇸
Georgetown University Medical Center, Washington, District of Columbia, United States

and more 4 locations

Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101

Phase 2

Terminated

Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Interventions: Drug: tesevatinib

First Posted Date: 2015-11-26

Last Posted Date: 2022-05-25

Lead Sponsor: Kadmon Corporation, LLC

Target Recruit Count: 15

Registration Number: NCT02616055

Locations: 🇺🇸
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States
🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

and more 3 locations

KD019 and Trastuzumab in Patients With Esophagus, Gastroesophageal Junction and Stomach Cancer

Phase 1

Withdrawn

Conditions: Stomach Cancer
Esophageal Cancer

Interventions: Drug: KD019

First Posted Date: 2014-07-31

Last Posted Date: 2014-08-01

Lead Sponsor: NYU Langone Health

Registration Number: NCT02205463

Locations: 🇺🇸
NYU Langone Medical Center, New York, New York, United States

Study of the Combination of KD019 and Trastuzumab in Subjects With HER2-Positive Metastatic Breast Cancer

Phase 1

Terminated

Conditions: HER-2 Positive Breast Cancer
Metastatic Malignant Neoplasm to Brain

Interventions: Drug: Tesevatinib
Drug: Trastuzumab

First Posted Date: 2014-06-03

Last Posted Date: 2022-04-27

Lead Sponsor: Kadmon Corporation, LLC

Target Recruit Count: 17

Registration Number: NCT02154529

Locations: 🇺🇸
Laura and Isaac Perlmutter Cancer Center @ NYU Langone, New York, New York, United States
🇺🇸
UC San Diego Moores Cancer Center, La Jolla, California, United States
🇺🇸
San Juan Oncology, Farmington, New Mexico, United States

and more 3 locations

A Safety, Pharmacokinetic & Dose-Escalation Study of KD019 in Subjects With Autosomal Dominant Polycystic Kidney Disease

Phase 1

Completed

Conditions: Polycystic Kidney, Autosomal Dominant

Interventions: Drug: Tesevatinib

First Posted Date: 2012-03-21

Last Posted Date: 2022-11-08

Lead Sponsor: Kadmon, a Sanofi Company

Target Recruit Count: 69

Registration Number: NCT01559363

Locations: 🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States
🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
🇺🇸
University of Colorado Denver, Denver, Colorado, United States

and more 8 locations

KD019 Versus Erlotinib in Subjects With Stage IIIB/IV Non Small Cell Lung Cancer With Progression After First- or Second-Line Chemotherapy

Phase 3

Terminated

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: KD019
Drug: Erlotinib

First Posted Date: 2011-12-07

Last Posted Date: 2022-05-13

Lead Sponsor: Kadmon Corporation, LLC

Target Recruit Count: 8

Registration Number: NCT01487174

Locations: 🇺🇸
Yale Cancer Center, New Haven, Connecticut, United States
🇺🇸
San Juan Oncology Associates, Farmington, New Mexico, United States

Safety Study of XL647 and XL147 Administered in Combination Daily in Adults With Solid Tumors

Phase 1

Withdrawn

Conditions: Cancer
Non-small-cell Lung Cancer
Breast Cancer

Interventions: Drug: XL647
Drug: XL147

First Posted Date: 2008-06-24

Last Posted Date: 2015-08-20

Lead Sponsor: Exelixis

Registration Number: NCT00704392

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York City, New York, United States
🇺🇸
South Texas Accelerated Research Therapeutics, San Antonio, Texas, United States

Drug Development Updates

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