TVB-2640 for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byDavid Gerber, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: David E Gerber

No Placebo Group

Prior Safety Data

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.

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.

+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.

+10 more

Participant Groups

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.

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.