Phase 2 Study of TVB-2640 in KRAS Non-Small Cell Lung Carcinomas

Status Recruiting

Clinical Trial Summary

This is a prospective one-arm, two-stage phase 2 trial of TVB-2640 in KRAS mutant NSCLC patients. 13 patients will be treated with a minimum of 1 cycle of TVB-2640 therapy over 8 weeks.

Clinical Trial Description

Patients with stable disease or partial/complete remissions will continue therapy. The endpoints are response rate-RR, disease control rate-DCR, PFS-progression-free survival, CTCAEv5.0 toxicities, plasma lipid levels, collection of sebaceous secretion via Sebutape, and 11C-acetate PET tumor imaging. In the first stage, 13 patients will be enrolled. If fewer than 2 patients achieve response, the study will be stopped. If 2 or more patients have a radiographic response, an additional 21 patients will be enrolled , for a total accrual of 34 patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03808558
Study type	Interventional
Source	University of Texas Southwestern Medical Center
Contact	Ebele Mbanugo, PhD
Phone	214-648-7097
Email	Ebele.mbanugo@UTSouthwestern.edu
Status	Recruiting
Phase	Phase 2
Start date	September 11, 2019
Completion date	December 1, 2026

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See also
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