NCT03808558 is a Phase 2 clinical trial of TVB-2640 in KRAS Gene Mutation, sponsored by David E Gerber.

Who is sponsoring NCT03808558?

NCT03808558 is sponsored by David E Gerber.

What drugs are being tested in NCT03808558?

Interventions in NCT03808558: TVB-2640.

What condition does NCT03808558 study?

NCT03808558 studies KRAS Gene Mutation.

Is NCT03808558 still recruiting?

NCT03808558 is currently active, enrolled. Last updated 8 January 2026.

Last reviewed 2026-01-08 · How we verify

NCT03808558

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 2 Last updated 8 January 2026

What this trial tests

Phase 2 trial testing TVB-2640 in KRAS Gene Mutation in 18 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

11 September 2019

Primary endpoint
3 April 2025

1 December 2026

Quick facts

Lead sponsor	David E Gerber
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	11 September 2019
Primary completion	3 April 2025
Estimated completion	1 December 2026
Sites	2 locations across United States

Drugs / interventions tested

TVB-2640 — full drug profile →

Conditions studied

KRAS Gene Mutation — all drugs for KRAS Gene Mutation →

Sponsor

David E Gerber

Who can join

18 and older, any sex, with KRAS Gene Mutation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting cancer metabolism in the era of precision oncology.
Stine ZE, Schug ZT, Salvino JM, Dang CV. · · 2022 · cited 839× · PMID 34862480 · DOI 10.1038/s41573-021-00339-6
Lipid metabolism and cancer.
Bian X, Liu R, Meng Y, Xing D, et al · · 2021 · cited 738× · PMID 33601415 · DOI 10.1084/jem.20201606
Tumor biomarkers for diagnosis, prognosis and targeted therapy.
Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2
Fatty Acid Synthase: An Emerging Target in Cancer.
Fhu CW, Ali A. · · 2020 · cited 276× · PMID 32872164 · DOI 10.3390/molecules25173935
Altered metabolism in cancer: insights into energy pathways and therapeutic targets.
Tufail M, Jiang CH, Li N. · · 2024 · cited 265× · PMID 39294640 · DOI 10.1186/s12943-024-02119-3
Lipogenesis inhibitors: therapeutic opportunities and challenges.
Batchuluun B, Pinkosky SL, Steinberg GR. · · 2022 · cited 260× · PMID 35031766 · DOI 10.1038/s41573-021-00367-2
Lipid metabolism in cancer progression and therapeutic strategies.
Fu Y, Zou T, Shen X, Nelson PJ, et al · · 2021 · cited 252× · PMID 34766135 · DOI 10.1002/mco2.27
First-in-human study of the safety, pharmacokinetics, and pharmacodynamics of first-in-class fatty acid synthase inhibitor TVB-2640 alone and with a taxane in advanced tumors.
Falchook G, Infante J, Arkenau HT, Patel MR, et al · · 2021 · cited 222× · PMID 33870151 · DOI 10.1016/j.eclinm.2021.100797

Verify or expand the search:

Other trials of TVB-2640

Trials testing the same drug.

NCT05743621 — Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer · Phase 1 · recruiting
NCT04906421 — Study of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (NASH) · Phase 2 · completed
NCT04352361 — Ascending Single-dose Study to Evaluate TVB-2640 in Chinese Healthy Subjects · Phase 1 · completed
NCT02980029 — TVB 2640 for Resectable Colon Cancer Other Resectable Cancers; a Window Trial. · Phase 1 · terminated
NCT03032484 — TVB- 2640 in Combination With Bevacizumab in Patients With First Relapse of High Grade Astrocytoma · Phase 2 · completed

Other recruiting trials for KRAS Gene Mutation

Currently open trials in the same condition.

NCT03087071 — Panitumumab With or Without Trametinib in Treating Patients With Stage IV Colorectal Cancer · Phase 2 · active not recruiting
NCT03065387 — Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic · Phase 1 · active not recruiting
NCT02642042 — Trametinib and Docetaxel in Treating Patients With Recurrent or Stage IV KRAS Mutation Positive Non-small Cell Lung Canc · Phase 2 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03808558 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by David E Gerber
Last refreshed: 8 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03808558.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing