NCT02980029

TVB 2640 for Resectable Colon Cancer Other Resectable Cancers; a Window Trial.

Terminated Phase 1 Last updated 22 October 2024

What this trial tests

Phase 1 trial testing TVB-2640 in Colon Cancer in 23 participants. Terminated before completion.

Timeline

6 October 2017

Primary endpoint
22 October 2023

22 October 2023

Quick facts

Lead sponsor	Mark Evers
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	23
Start date	6 October 2017
Primary completion	22 October 2023
Estimated completion	22 October 2023
Sites	1 location across United States

Drugs / interventions tested

• TVB-2640 — full drug profile →
• Placebo

Conditions studied

• Colon Cancer — all drugs for Colon Cancer →

Sponsor

Mark Evers

Who can join

Adults 18 to 99, any sex, with Colon Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary Objective

• To evaluate the pharmacodynamic effects on metabolic endpoints (malonyl carnitine and tripalmitin levels) following short-term treatment with TVB-2640 in patients with resectable cancers

Secondary Objectives

* To determine if short-term treatment with TVB-2640 decreases cancer cell proliferation.
* To examine other biological endpoints and determine if TVB-2640 inhibits cell survival signaling and lipid biogenesis.
* To perform comprehensive metabolomic analysis in tumor tissues to identify metabolic alterations induced by TVB-2640 treatment.
* To correlate FASN levels in tumor with metabolic and biological endpoints to determine if FASN inhibition has more pronounced effects in patients with increased expression.

Publications & conference data

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

1. 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
2. Fatty Acid Synthase: An Emerging Target in Cancer.
   Fhu CW, Ali A. · · 2020 · cited 276× · PMID 32872164 · DOI 10.3390/molecules25173935
3. 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
4. Lipogenesis inhibitors: therapeutic opportunities and challenges.
   Batchuluun B, Pinkosky SL, Steinberg GR. · · 2022 · cited 260× · PMID 35031766 · DOI 10.1038/s41573-021-00367-2
5. Inhibition of de novo lipogenesis targets androgen receptor signaling in castration-resistant prostate cancer.
   Zadra G, Ribeiro CF, Chetta P, Ho Y, et al · · 2019 · cited 236× · PMID 30578319 · DOI 10.1073/pnas.1808834116
6. Acetyl-CoA metabolism in cancer.
   Guertin DA, Wellen KE. · · 2023 · cited 219× · PMID 36658431 · DOI 10.1038/s41568-022-00543-5
7. The Metabolic Landscape of RAS-Driven Cancers from biology to therapy.
   Mukhopadhyay S, Vander Heiden MG, McCormick F. · · 2021 · cited 212× · PMID 33870211 · DOI 10.1038/s43018-021-00184-x
8. Cancer cell metabolism and antitumour immunity.
   De Martino M, Rathmell JC, Galluzzi L, Vanpouille-Box C. · · 2024 · cited 183× · PMID 38649722 · DOI 10.1038/s41577-024-01026-4