NCT03808558

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

A Phase 2 Multi-center Pharmacodynamics Study of TVB-2640 in KRAS Mutant Non-small Cell Lung Carcinomas

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: David E Gerber · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• KRAS Gene Mutation

Interventions

Type	Name	Description
DRUG	TVB-2640	TVB-2640 will be administered 100mg/m2 orally once a day for 8 weeks.

Timeline

• Start date: 2019-09-11
• Primary completion: 2025-04-03
• Completion: 2026-12-01
• First posted: 2019-01-17
• Last updated: 2026-01-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study