18 Participants Needed

TVB-2640 for Non-Small Cell Lung Cancer

Recruiting at 1 trial location
JS
DG
JW
EM
Overseen ByEbele Mbanugo, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use strong CYP3A4/5 agonists or inhibitors during the study. It's best to discuss your current medications with the study team to ensure they don't interfere with the trial.

Research Team

DG

David Gerber, MD

Principal Investigator

Professor

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.
My cancer has a KRAS mutation confirmed by a certified test.
My cancer has worsened despite my latest treatment.
See 10 more

Exclusion Criteria

I have HIV or hepatitis B/C.
I need to take strong medication that affects liver enzymes during the study.
I don't have another cancer that could affect this treatment's safety or results.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TVB-2640 100mg/m2 orally once a day for 8 weeks

8 weeks
Visits every 4 weeks for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Patients with stable disease or partial/complete remissions will continue therapy

Until disease progression or unacceptable toxicity

Treatment Details

Interventions

  • TVB-2640
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

David E Gerber

Lead Sponsor

Trials
1
Recruited
20+

Gateway for Cancer Research

Collaborator

Trials
47
Recruited
2,500+

Sagimet Biosciences Inc.

Industry Sponsor

Trials
10
Recruited
3,900+

Cancer Prevention Research Institute of Texas

Collaborator

Trials
55
Recruited
98,900+