CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 18 enrolled
Drug / intervention
TVB-2640drug
Likely dose
TVB-2640 100 mg/m² orally once daily for 8 weeksAI-extracted
Key inclusion· 8
  • ✓Metastatic or advanced NSCLC with oncogenic KRAS mutation confirmed by CLIA-certified assay (tissue or blood-based)
  • ✓Prior treatment with doublet chemotherapy AND immune checkpoint inhibitor (unless contraindicated)
  • ✓Known EGFR mutation and ALK rearrangement status; if present, must have progressed after appropriate FDA-approved targeted therapy
  • ✓Evidence of disease progression on most recent therapy
Key exclusion· 12
  • ✕Unable to swallow oral medications or significant GI dysfunction/disease impairing absorption (active IBD, uncontrolled nausea, vomiting, diarrhea, malabsorption)
  • ✕Risk factors for torsade de pointes: uncontrolled heart failure, severe hypokalemia (K <3mM/L), long QT syndrome history, or need for QT-prolonging medications
  • ✕Requires strong CYP3A4/5 agonists or inhibitors during study
  • ✕Uncontrolled or severe intercurrent medical condition including uncontrolled brain metastases

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03808558
NCT03808558Phase 2Active
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A Phase 2 Multi-center Pharmacodynamics Study of TVB-2640 in KRAS Mutant Non-small Cell Lung Carcinomas

David E Gerber·interventional·Posted Jan 17, 2019·Updated May 22, 2026

In Brief

A Phase 2 clinical trial evaluating TVB-2640 for KRAS Gene Mutation. Active but no longer recruiting, targeting 18 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKRAS Gene Mutation
CountriesUnited States
CollaboratorsSagimet Biosciences Inc., Cancer Prevention Research Institute of Texas, Gateway for Cancer Research

Timeline

Phase 2Active
201920202021202220232024202520262027
First PostedJan 17, 2019
Enrollment StartSep 11, 2019
Primary CompletionApr 3, 2025
Study CompletionDec 1, 2026
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 7.5 years ago

Interventions

TVB-2640drug

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