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TVB-2640

DRUG7 trials

Sponsors

Sagimet Biosciences Inc., Mark Evers, The University of Texas Health Science Center at San Antonio, David E Gerber, Ascletis Pharmaceuticals Co., Ltd.

Conditions

AstrocytomaColon CancerHealthyKRAS Gene MutationMetabolic Dysfunction-assocated Steatohepatitis/ Nonalcoholic Fatty Liver DiseaseProstatic Neoplasms, Castration-ResistantSolid Malignant Tumor

Phase 1

A Phase 1, First-In-Human Study of Escalating Doses of Oral TVB-2640 in Patients With Solid Tumors
CompletedNCT02223247
Sagimet Biosciences Inc.Solid Malignant Tumor
Start: 2013-11-30End: 2017-06-30Target: 180Updated: 2017-08-14
TVB 2640 for Resectable Colon Cancer Other Resectable Cancers; a Window Trial.
TerminatedNCT02980029
Mark EversColon Cancer
Start: 2017-10-06End: 2023-10-22Updated: 2024-10-22
Ascending Single-dose Study to Evaluate TVB-2640 in Chinese Healthy Subjects
CompletedNCT04352361
Ascletis Pharmaceuticals Co., Ltd.Healthy
Start: 2020-04-02End: 2020-04-29Updated: 2020-07-07
Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer
RecruitingNCT05743621
Weill Medical College of Cornell UniversityProstatic Neoplasms, Castration-Resistant
Start: 2023-11-20End: 2029-01-25Target: 30Updated: 2025-11-21

Phase 2

TVB- 2640 in Combination With Bevacizumab in Patients With First Relapse of High Grade Astrocytoma
CompletedNCT03032484
The University of Texas Health Science Center at San AntonioAstrocytoma
Start: 2017-05-18End: 2021-04-05Updated: 2023-06-15
Phase 2 Study of TVB-2640 in KRAS Non-Small Cell Lung Carcinomas
Active, not recruitingNCT03808558
David E GerberKRAS Gene Mutation
Start: 2019-09-11End: 2026-12-01Updated: 2026-05-22
Study of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (NASH)
CompletedNCT04906421
Sagimet Biosciences Inc.Metabolic Dysfunction-assocated Steatohepatitis/ Nonalcoholic Fatty Liver Disease
Start: 2021-08-12End: 2023-10-02Updated: 2025-05-09

Related Papers

A phase 2 multi-center pharmacodynamic study of the fatty acid synthase (FASN) inhibitor TVB-2640 in advanced <i>KRAS</i> -mutant non–small cell lung cancer.
Journal of Clinical Oncology2026-05-27
Denifanstat for the treatment of metabolic dysfunction-associated steatohepatitis: a multicentre, double-blind, randomised, placebo-controlled, phase 2b trial.
2024-10-1145 citations
A phase I, open-label, dose-finding study of fatty acid synthase (FASN) inhibitor TVB-2640 administered in combination with enzalutamide (Enza) in men with metastatic castration-resistant prostate cancer (mCRPC).
Journal of Clinical Oncology2024-01-291 citations
First-in-human study of the safety, pharmacokinetics, and pharmacodynamics of first-in-class fatty acid synthase inhibitor TVB-2640 alone and with a taxane in advanced tumors.
2021-03-30213 citations
Prospective phase II trial in patients with first relapse of high-grade astrocytoma using TVB-2640 in combination with bevacizumab versus bevacizumab alone.
Journal of Clinical Oncology2019-05-209 citations
ACTR-25. UPDATED RESULTS FROM A PROSPECTIVE, RANDOMIZED PHASE 2 STUDY IN PATIENTS WITH FIRST RELAPSE OF HIGH-GRADE ASTROCYTOMA USING TVB-2640 IN COMBINATION WITH AVASTIN VERSUS AVASTIN ALONE
Neuro-Oncology2018-11-014 citations
A phase 2 study to determine the efficacy and safety of TVB-2640 in combination with bevacizumab in patients with first relapse of high grade astrocytoma.
Journal of Clinical Oncology2017-05-204 citations
Preliminary activity in the first in human study of the first-in-class fatty acid synthase (FASN) inhibitor, TVB-2640.
Journal of Clinical Oncology2016-05-2043 citations
Abstract A54: First-in-human study of the first-in-class fatty acid synthase (FASN) inhibitor, TVB-2640 as monotherapy or in combination - final results of dose escalation
Molecular Cancer Therapeutics2015-12-017 citations
Abstract B13: Biomarker Analyses from Dose Escalation Phase of FASN Inhibitor TVB-2640 Phase 1 Study Shows Target Engagement in Solid Tumor Patients
Molecular Cancer Therapeutics2015-12-011 citations
Abstract CT203: Report of a first-in-human study of the first-in-class fatty acid synthase (FASN) inhibitor TVB-2640
Cancer Research2015-08-0112 citations
First-in-human investigation of the oral first-in-class fatty acid synthase (FASN) inhibitor, TVB-2640.
Journal of Clinical Oncology2015-05-2017 citations