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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    12
  • sponsor
    David E Gerber
Updated on 6 March 2022

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.

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.

Details
Condition KRAS Gene Mutation
Treatment TVB-2640
Clinical Study IdentifierNCT03808558
SponsorDavid E Gerber
Last Modified on6 March 2022

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