Evidence map›Paper›PMID 33870151›Full record

ArticleEClinicalMedicine2021

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.

Gerald Falchook, Jeffrey Infante, Hendrik-Tobias Arkenau, Manish R Patel, Emma Dean, Erkut Borazanci, Andrew Brenner, Natalie Cook, Juanita Lopez, Shubham Pant and 8 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02223247 (A Phase 1, First-In-Human Study of Escalating Doses of Oral TVB-2640 in Patients With Solid Tumors), which is not on this map. Cited by 218 papers.

0numbers the graph read from it
0cells of the map it votes in
218citing papers in PubMed
15.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02223247 phase1completednot on this map

A Phase 1, First-In-Human Study of Escalating Doses of Oral TVB-2640 in Patients With Solid Tumors

TypeinterventionalSponsorSagimet Biosciences Inc.Ran2013 to 2017Enrolled180ConditionsSolid Malignant TumorArmsTVB-2640
3 · Its place in the literature

Who cites it

218 citing papers in PubMed, 256 citations in OpenAlex.

  1. Phase II Investigation of TVB-2640 (Denifanstat) with Bevacizumab in Patients with First Relapse High-Grade Astrocytoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Trial
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  16. Genomic alterations and their correlation with metabolic-related genes in lung cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
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158 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 12 institutions in 2 countries.

Gerald FalchookSarah Cannon Research Institute at HealthONE, 1800 Williams St Ste 300, Denver, CO, 80218, United States.
Jeffrey InfanteTennessee Oncology, 250 25th Ave N #100, Nashville, TN 37203, United States.
Hendrik-Tobias ArkenauSarah Cannon Research Institute UK, 93 Harley St., Marylebone, London W1G 6AD, United Kingdom.
Manish R PatelFlorida Cancer Specialists and Research Institute, 600 N Cattleman Rd, Ste 200, Sarasota, FL 34232, United States.
Emma DeanChristie Hospital - Clinical Oncology, The Christie NHS Foundation Trust, Clinical Oncology Department, Wilmslow Road, Manchester, M20 4BX, United Kingdom.
Erkut BorazanciScottsdale Healthcare Research Institute, 10510 North 92nd Street, Suite 200, Scottsdale, AZ 85258, United States.
Andrew BrennerCTRC at The University of Texas Health Center, 7979 Wurzbach Rd., San Antonio, TX 78229, United States.
Natalie CookChristie Hospital - Clinical Oncology, The Christie NHS Foundation Trust, Clinical, Oncology Department, Wilmslow Road, Manchester, M20 4BX, United Kingdom.
Juanita LopezRoyal Marsden Hospital, Downs Road, Sutton, SM25PT, United Kingdom.
Shubham PantUniversity of Oklahoma Health Sciences, 800 NE 10 Street, 5th Floor, Oklahoma City, OK 73104, United States.
Arthur FrankelUT Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390, United States.
Peter SchmidSt Bartholomew's Hospital, West Smithfield, London, EC1A7BE, United Kingdom.
Kathleen MooreUniversity of Oklahoma Health Sciences, 800 NE 10 Street, 5th Floor, Oklahoma City, OK 73104, United States.
William McCullochSagimet Biosciences Inc., 155 Bovet Rd., San Mateo, CA 94402, United States.
Katharine GrimmerSagimet Biosciences Inc., 155 Bovet Rd., San Mateo, CA 94402, United States.
Marie O'FarrellSagimet Biosciences Inc., 155 Bovet Rd., San Mateo, CA 94402, United States.
George KembleSagimet Biosciences Inc., 155 Bovet Rd., San Mateo, CA 94402, United States.
Howard BurrisSarah Cannon Research Institute, 1100 Martin L. King Jr. Boulevard, Nashville, TN 37203 United States.
Sarah Cannon · USUniversity of Oklahoma Health Sciences Center · USHealthONE · USRoyal Marsden Hospital · GBSarah Cannon Research Institute · GBScottsdale Research Institute (United States) · USSouthwestern Medical Center · USSt Bartholomew's Hospital · GBTennessee Oncology · USThe Christie NHS Foundation Trust · GBThe University of Texas Health Science Center at San Antonio · USUniversity of Manchester · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe conducted a first-in-human dose-escalation study with the oral FASN inhibitor TVB-2640 to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D), as monotherapy and with a taxane.

methodsThis completed open-label outpatient study was conducted at 11 sites in the United States and United Kingdom. Patients with previously-treated advanced metastatic solid tumors and adequate performance status and organ function were eligible. TVB-2640 was administered orally daily until PD. Dose escalation initially followed an accelerated titration design that switched to a standard 3 + 3 design after Grade 2 toxicity occurred. Disease-specific cohorts were enrolled at the MTD. Statistical analyses were primarily descriptive. Safety analyses were performed on patients who received at least 1 dose of study drug. (Clinicaltrials.gov identifier NCT02223247).

findingsThe study was conducted from 21 November 2013 to 07 February 2017. Overall, 136 patients received TVB-2640, 76 as monotherapy (weight-based doses of 60 mg/m

interpretationTVB-2640 demonstrated potent FASN inhibition and a predictable and manageable safety profile, primarily characterized by non-serious, reversible adverse events affecting skin and eyes. Further investigation of TVB-2640 in patients with solid tumors, particularly in KRAS

fundingThis trial was funded by 3-V Biosciences, Inc. (now known as Sagimet Biosciences Inc.).

Indexed as

BiomarkersBreast cancerClinical trialsDrug mechanismsGynecological cancersLung cancerPharmacologySmall molecule agents

Identifiers

PMID33870151
PMCPMC8040281
OpenAlexW3145730155

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.