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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
Age ≥ 18 years
Molecular characterization (tissue- or blood-based [ie, cell-free/circulating tumor DNA]) must have been performed and must have demonstrated an oncogenic KRAS mutation (e.g., exon 12, 13, 61, or 117 mutation detected by sequencing) by a CLIA-certified assay (source documentation required). KRAS mutations at other codons require review and approval by Study Chair
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial will test a new cancer drug, TVB-2640, on patients with a specific type of non-small cell lung cancer.
Who is the study for?
This trial is for adults with advanced stage Non-Small Cell Lung Cancer (NSCLC) that has a specific KRAS mutation and has worsened despite previous treatments including chemotherapy and immune therapy. Participants must have good organ function, no severe heart disease or infections, not be pregnant, and agree to use contraception.Check my eligibility
What is being tested?
The study tests TVB-2640 in patients with KRAS mutant NSCLC. It's a phase 2 trial where all participants receive the drug over an 8-week period to see how effective it is against their cancer after other treatments have failed.See study design
What are the potential side effects?
Potential side effects of TVB-2640 may include allergic reactions if there's a history of hypersensitivity, issues from impaired GI function affecting drug absorption, risks related to heart conditions like torsade de pointes due to QT interval prolongation, and complications from active infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My cancer has a KRAS mutation confirmed by a certified test.
Select...
My cancer has worsened despite my latest treatment.
Select...
My advanced lung cancer has a KRAS mutation.
Select...
I am fully active or can carry out light work.
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My blood counts and organ functions are within normal ranges.
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I haven't had a heart attack or major heart issues in the last 6 months.
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I know my cancer's EGFR and ALK status and have tried all FDA-approved treatments for them.
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
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 moreSide effects data
From 2021 Phase 2 trial • 25 Patients • NCT0303248478%
Palmar plantar erythrodysesthesia syndrome
65%
Mucositis
57%
Hypertension
52%
Dry Eye
30%
Fatigue
22%
Muscle weakness
22%
alopecia
22%
Skin infection
17%
Arthralgia
17%
Myalgia
13%
Elevated ALT/AST
13%
Allergic rhinitis
13%
Constipation
13%
Hoarseness
13%
Parestheisa
13%
Headache
13%
Depression
13%
Dysphasia
9%
Upper respiratory tract infection
9%
Urinary Tract Infection
9%
Cognitive Disturbance
9%
Conjunctivitis
9%
Diarrhea
9%
Dry Mouth
9%
Dry Skin
9%
Limb edema
9%
Hypokalemia
9%
Pruritis
4%
Acute kidney injury
4%
Anorexia
4%
Aphasia
4%
Bronchitis
4%
Confusion
4%
Increased Creatinine
4%
Thromboembolic event
4%
Vomiting
4%
Wound infection
4%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab and TVB-2640
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
~550
Find a Location
Who is running the clinical trial?
Sagimet Biosciences Inc.Industry Sponsor
7 Previous Clinical Trials
582 Total Patients Enrolled
David E GerberLead Sponsor
Cancer Prevention Research Institute of TexasOTHER
50 Previous Clinical Trials
98,404 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have HIV or hepatitis B/C.My cancer has a KRAS mutation confirmed by a certified test.I need to take strong medication that affects liver enzymes during the study.My cancer has worsened despite my latest treatment.I don't have another cancer that could affect this treatment's safety or results.You are expected to live for more than 3 months.I am currently being treated with IV antibiotics for a serious infection.My advanced lung cancer has a KRAS mutation.My KRAS mutant lung cancer has not responded to initial treatments including chemotherapy and immunotherapy.I cannot take pills by mouth or have a stomach condition that affects medication absorption.I have heart risks like severe low potassium or a history of long QT syndrome.I haven't had major surgery or cancer treatment close to starting TVB-2640, and any side effects are minimal.I am fully active or can carry out light work.My blood counts and organ functions are within normal ranges.I agree to use birth control or abstain from sex during and for 90 days after the study.I haven't had a heart attack or major heart issues in the last 6 months.You have had a serious lung reaction due to a drug, radiation, or immune system.I have stable brain metastases and haven't changed my medication dose in the last 4 weeks.I know my cancer's EGFR and ALK status and have tried all FDA-approved treatments for them.I have significant dry eye or corneal issues, or I won't stop wearing contacts for the study.I am currently pregnant or breastfeeding.Your disease can be measured using a specific method called RECIST v1.1.
Research Study Groups:
This trial has the following groups:- Group 1: TVB-2640
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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