CLINICAL TRIALS PROFILE FOR TVB-2640

Clinical Trials for TVB-2640

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT02223247 ↗	A Phase 1, First-In-Human Study of Escalating Doses of Oral TVB-2640 in Patients With Solid Tumors	Completed	3V Biosciences, Inc.	Phase 1	This first in human phase 1 study of TVB-2640 is being conducted in patients with advanced stage solid malignant tumors. This research is being done to find out how safe and useful TVB-2640 is for patients who have received previous cancer therapy, and for whom no therapy exists that would be curative or might provide significant benefit. TVB-2640 belongs to a class of drugs called fatty acid synthase inhibitors (FASN inhibitors). This means that they interfere with the body's (and the tumor's) ability to use a substance called fatty acid synthase (FASN). Research has shown that some tumors appear to need FASN to keep growing.
NCT02223247 ↗	A Phase 1, First-In-Human Study of Escalating Doses of Oral TVB-2640 in Patients With Solid Tumors	Completed	Sagimet Biosciences Inc.	Phase 1	This first in human phase 1 study of TVB-2640 is being conducted in patients with advanced stage solid malignant tumors. This research is being done to find out how safe and useful TVB-2640 is for patients who have received previous cancer therapy, and for whom no therapy exists that would be curative or might provide significant benefit. TVB-2640 belongs to a class of drugs called fatty acid synthase inhibitors (FASN inhibitors). This means that they interfere with the body's (and the tumor's) ability to use a substance called fatty acid synthase (FASN). Research has shown that some tumors appear to need FASN to keep growing.
NCT02980029 ↗	TVB 2640 for Resectable Colon Cancer Other Resectable Cancers; a Window Trial.	Recruiting	Mark Evers	Phase 1	Primary Objective • To evaluate the pharmacodynamic effects on metabolic endpoints (malonyl carnitine and tripalmitin levels) following short-term treatment with TVB-2640 in patients with resectable cancers Secondary Objectives - To determine if short-term treatment with TVB-2640 decreases cancer cell proliferation. - To examine other biological endpoints and determine if TVB-2640 inhibits cell survival signaling and lipid biogenesis. - To perform comprehensive metabolomic analysis in tumor tissues to identify metabolic alterations induced by TVB-2640 treatment. - To correlate FASN levels in tumor with metabolic and biological endpoints to determine if FASN inhibition has more pronounced effects in patients with increased expression.
NCT02980029 ↗	TVB 2640 for Resectable Colon Cancer Other Resectable Cancers; a Window Trial.	Recruiting	University of Kentucky	Phase 1	Primary Objective • To evaluate the pharmacodynamic effects on metabolic endpoints (malonyl carnitine and tripalmitin levels) following short-term treatment with TVB-2640 in patients with resectable cancers Secondary Objectives - To determine if short-term treatment with TVB-2640 decreases cancer cell proliferation. - To examine other biological endpoints and determine if TVB-2640 inhibits cell survival signaling and lipid biogenesis. - To perform comprehensive metabolomic analysis in tumor tissues to identify metabolic alterations induced by TVB-2640 treatment. - To correlate FASN levels in tumor with metabolic and biological endpoints to determine if FASN inhibition has more pronounced effects in patients with increased expression.
NCT03032484 ↗	TVB- 2640 in Combination With Bevacizumab in Patients With First Relapse of High Grade Astrocytoma	Active, not recruiting	The University of Texas Health Science Center at San Antonio	Phase 2	Randomized phase 2 study TVB-2640 in combination with Bevacizumab versus Bevacizumab alone.

Clinical Trial Conditions for TVB-2640

Condition Name

Condition Name
Intervention	Trials
Stage IIIA Breast Cancer	1
HER2 Positive Breast Carcinoma	1
Stage IIIA Breast Cancer AJCC v7	1
KRAS Gene Mutation	1

Condition MeSH

Condition MeSH
Intervention	Trials
Non-alcoholic Fatty Liver Disease	3
Liver Diseases	3
Fatty Liver	3
Breast Neoplasms	1

Clinical Trial Locations for TVB-2640

Trials by Country

Trials by Country
Location	Trials
United States	45
China	6
Canada	4
Puerto Rico	1
United Kingdom	1

Trials by US State

Trials by US State
Location	Trials
Texas	6
Florida	5
Arizona	3
North Carolina	2
California	2

Clinical Trial Progress for TVB-2640

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	5
Phase 1	6

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Recruiting	4
Completed	3
Not yet recruiting	3

Clinical Trial Sponsors for TVB-2640

Sponsor Name

Sponsor Name
Sponsor	Trials
Sagimet Biosciences Inc.	7
Ascletis Pharmaceuticals Co., Ltd.	2
3V Biosciences, Inc.	2

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	11
Other	8
NIH	1