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

Phase 2

Active, not recruiting

• Conditions: KRAS Gene Mutation
• Interventions: Drug: TVB-2640

• Registration Number: NCT03808558
• Lead Sponsor: David E Gerber

Brief 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.

Study Timeline

• Study First Submitted: 2018-05-24
• Study First Submitted QC: 2019-01-15
• Study First Posted: 2019-01-17
• Study Start: 2019-09-11
• Status Verified: 2024-12
• Primary Completion: 2025-04-03
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TVB-2640	TVB-2640	Patients will be administered TVB-2640 100mg/m2 orally once a day for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Disease control rate of TVB-2640	every 8 weeks through study completion, an average of 1 year	Determine Disease control rate of TVB-2640 in KRAS mutant NSCLC patients through RECIST and toxicity profile.
Response rate of TVB-2640	every 8 weeks through study completion, an average of 1 year	Determine response rate of TVB-2640 in KRAS mutant NSCLC patients through RECIST and toxicity profile.

Secondary Outcome Measures

Name	Time	Method
Establish the predictive value of 11C-acetate PET	Pretreatment and four weeks of treatment.	To establish the predictive value of 11C-acetate PET pretreatment and post-treatment tumor uptake for disease control rate and response rate
Safety profile of TVB-2640	Pretreatment and four weeks of treatment.	Secondary endpoints are 11C-acetate tumor uptake pretreatment and at four weeks of treatment and plasma lipidomics pretreatment and at four weeks of treatment.
Mean change in sebaceous secretion of fatty acids	Pretreatment and four weeks of treatment.	Sebutabe collection of sebaceous secretion of fatty acids will be performed at baseline and four weeks of treatment
Mean change in fasting plasma lipidomics	Pretreatment and four weeks of treatment.	Blood samples for fasting plasma lipidomics will be collected at baseline and four weeks of treatment.

Trial Locations

Locations (2)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States