drugset / Trial / NCT02223247

A Phase 1, First-In-Human Study of Escalating Doses of Oral TVB-2640 in Patients With Solid Tumors

NCT02223247

Phase 1 Completed 180 enrolled Sagimet Biosciences Inc.
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2013-11
Primary completion
2017-06
Completion
2017-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Denifanstat Small molecule 60 mg/m2 Oral
Subject Denifanstat Small molecule 100 mg/m2 Oral
Subject Denifanstat Small molecule 200 mg Oral
Subject Denifanstat Small molecule 240 mg/m2 Oral
Subject Denifanstat Small molecule 250 mg Oral

Indications