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Fatty Acid Synthase Inhibitor

TVB-2640 for Non-Small Cell Lung Cancer

Phase 2

Recruiting

Led By David Gerber, MD

Research Sponsored by David E Gerber

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Metastatic or advanced stage, histologically or cytologically confirmed NSCLC and molecular identification of oncogenic KRAS mutation.

KRAS mutant NSCLC must be refractory, relapsed, and previously treated with doublet chemotherapy and immune checkpoint inhibitor (unless there is a specific contraindication to checkpoint inhibitor).

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upevery 8 weeks through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Study Summary

This trial will test a new cancer drug, TVB-2640, on patients with a specific type of non-small cell lung cancer.

Eligible Conditions

KRAS Gene Mutation

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 8 weeks through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 8 weeks through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease control rate of TVB-2640

Response rate of TVB-2640

Secondary outcome measures

Establish the predictive value of 11C-acetate PET

Mean change in fasting plasma lipidomics

Mean change in sebaceous secretion of fatty acids

+1 more

Side effects data

From 2021 Phase 2 trial • 25 Patients • NCT03032484

78%

Palmar plantar erythrodysesthesia syndrome

65%

Mucositis

57%

Hypertension

52%

Dry Eye

30%

Fatigue

22%

Skin infection

22%

Muscle weakness

22%

alopecia

17%

Arthralgia

17%

Myalgia

13%

Elevated ALT/AST

13%

Allergic rhinitis

13%

Constipation

13%

Parestheisa

13%

Hoarseness

13%

Headache

13%

Depression

13%

Dysphasia

Upper respiratory tract infection

Urinary Tract Infection

Cognitive Disturbance

Conjunctivitis

Diarrhea

Dry Mouth

Dry Skin

Limb edema

Hypokalemia

Pruritis

Acute kidney injury

Anorexia

Aphasia

Bronchitis

Confusion

Increased Creatinine

Thromboembolic event

Vomiting

Wound infection

Seizure

100%

80%

60%

40%

20%

Study treatment Arm

Bevacizumab and TVB-2640

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TVB-2640Experimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TVB-2640

2019

Completed Phase 2

~390

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cancer Prevention Research Institute of TexasOTHER

49 Previous Clinical Trials

98,239 Total Patients Enrolled

David E GerberLead Sponsor

Sagimet Biosciences Inc.Industry Sponsor

7 Previous Clinical Trials

582 Total Patients Enrolled

Media Library

TVB-2640 (Fatty Acid Synthase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03808558 — Phase 2

KRAS Mutation Research Study Groups: TVB-2640

KRAS Mutation Clinical Trial 2023: TVB-2640 Highlights & Side Effects. Trial Name: NCT03808558 — Phase 2

TVB-2640 (Fatty Acid Synthase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03808558 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the goals that researchers hope to achieve with this clinical trial?

"The main goal of this trial is to assess the disease control rate of TVB-2640 over the course of a year. Secondary objectives include assessing the mean change in sebaceous secretion of fatty acids, safety profile of TVB-2640, and mean change in fasting plasma lipidomics."

Answered by AI

How many people are taking part in this clinical trial?

"That is correct, the clinical trial is still looking for patients. The public information on the website was first posted on September 11th, 2019 and updated February 3rd, 2022. At this time, they are enrolling 12 individuals between 2 locations."

Answered by AI

Are people with the relevant medical condition able to participate in this trial currently?

"That is correct, the online clinicaltrials.gov database has information stating that this trial is still recruiting patients. The 12 subjects needed for this study are being recruited from 2 medical facilities, and the trial was first posted on September 11th, 2019 with its most recent edit on February 3rd, 2022."

Answered by AI

Is TVB-2640 able to be legally prescribed by doctors in the United States?

"TVB-2640 is currently in Phase 2 of clinical trials. While there is some evidence supporting its safety, there is none yet to suggest that it is an effective medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

David E Gerber 2019. "Phase 2 Study of TVB-2640 in KRAS Non-Small Cell Lung Carcinomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03808558.

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