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

NCT03808558 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-05-22

Study results available
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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.

Conditions

  • KRAS Gene Mutation

Interventions

DRUG

TVB-2640

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

Sponsors & Collaborators

  • Sagimet Biosciences Inc.

    collaborator INDUSTRY

  • Cancer Prevention Research Institute of Texas

    collaborator OTHER

  • Gateway for Cancer Research

    collaborator OTHER

  • David E Gerber

    lead OTHER

Principal Investigators

  • David Gerber, MD · Professor

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-11
Primary Completion
2025-04-03
Completion
2026-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03808558 on ClinicalTrials.gov