Tesevatinib

Overview

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.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD	2017/06/29	NCT03203642	Phase 2	Completed	Kadmon, a Sanofi Company
A Safety, Pharmacokinetic, Single Ascending Dose Study of Tesevatinib in Pediatric Subjects With Autosomal Recessive Polycystic Kidney Disease (ARPKD)	2017/03/30	NCT03096080	Phase 1	Completed	Kadmon Corporation, LLC
Study of Tesevatinib Monotherapy in Patients With Recurrent Glioblastoma	2016/07/26	NCT02844439	Phase 2	Completed	Kadmon Corporation, LLC
Phase 2 Study of Study of Tesevatinib in Subjects With NSCLC and Brain or Leptomeningeal Metastases	2015/11/26	NCT02616393	Phase 2	Completed	Kadmon Corporation, LLC
Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101	2015/11/26	NCT02616055	Phase 2	Terminated	Kadmon Corporation, LLC
KD019 and Trastuzumab in Patients With Esophagus, Gastroesophageal Junction and Stomach Cancer	2014/07/31	NCT02205463	Phase 1	Withdrawn	NYU Langone Health
Study of the Combination of KD019 and Trastuzumab in Subjects With HER2-Positive Metastatic Breast Cancer	2014/06/03	NCT02154529	Phase 1	Terminated	Kadmon Corporation, LLC
A Safety, Pharmacokinetic & Dose-Escalation Study of KD019 in Subjects With Autosomal Dominant Polycystic Kidney Disease	2012/03/21	NCT01559363	Phase 1	Completed	Kadmon, a Sanofi Company
KD019 Versus Erlotinib in Subjects With Stage IIIB/IV Non Small Cell Lung Cancer With Progression After First- or Second-Line Chemotherapy	2011/12/07	NCT01487174	Phase 3	Terminated	Kadmon Corporation, LLC
Safety Study of XL647 and XL147 Administered in Combination Daily in Adults With Solid Tumors	2008/06/24	NCT00704392	Phase 1	Withdrawn	Exelixis

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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