Active — Not RecruitingPhase 2

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

United States18 participantsStarted 2019-09-11

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Metastatic or advanced stage, histologically or cytologically confirmed NSCLC and molecular identification of oncogenic KRAS mutation.
✓. Subjects' EGFR mutation and ALK gene rearrangement status must be known prior to study entry. Subjects with EGFR mutation or ALK gene rearrangement must have progressed after appropriate FDA-approved targeted therapy options prior to eligibility.
✓. Patient has evidence of disease progression on most recent line of therapy.
✓. Patient has measurable disease by RECIST v1.1 (Eisenhauer, 2009).
✓. Age ≥ 18 years.
✓. ECOG performance status of 0 or 1.
✓. Predicted life expectancy of \>3 months.
✓. Adequate organ and marrow function as defined below:

Exclusion criteria

✕. Patient is unable to swallow oral medications or has impairment of GI function or GI disease that may significantly alter drug absorption such as active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome.
✕. Patient has a history of risk factors for torsade de pointes such as uncontrolled heart failure, severe hypokalemia with potassium less than 3mM/L, history of long QT syndrome or require use during study participation of concomitant medications known to prolong QT/QTc interval.
✕. Patients who require use of strong CYP3A4/5 agonists or inhibitors during study participation.
✕. Patient has uncontrolled or severe intercurrent medical condition including uncontrolled brain metastases. Patients with stable brain metastases either treated or untreated, on a stable dose of steroids/anticonvulsants, with no dose increase within 4 weeks before the first dose of TVB-2640, and no anticipated dose change, are allowed.
✕. Patient underwent major surgery within 4 weeks before the first dose of TVB-2640 or received cancer-directed therapy either chemotherapy, radiotherapy, hormonal therapy, biologic or immunotherapy, etc. or an investigational drug or device within 2 weeks (6 weeks for mitomycin C and nitrosoureas) or 5 half-lives of that agent, whichever is shorter before the first dose of TVB-2640. In addition, any drug- related toxicity, with the exception of alopecia, an endocrinopathy controlled with replacement therapy, or a clinically stable toxicity not expected to increase from study therapy (eg, cisplatin-associated ototoxicity) should have recovered to \<Grade 1.
✕. If female, patient is pregnant or breast-feeding.
✕. Patient has evidence of a serious active infection-infection requiring treatment with intravenous antibiotics.
✕. Patient has known immunodeficiency virus-HIV or hepatitis B or C infection, as such patients may be at increased risk for toxicity due to concomitant treatment and disease-related symptoms may preclude accurate assessment of the safety of TVB-2640.

What they're measuring

Disease control rate of TVB-2640

Timeframe: every 8 weeks through study completion, an average of 1 year

Response rate of TVB-2640

Timeframe: every 8 weeks through study completion, an average of 1 year

Trial details

NCT IDNCT03808558

SponsorDavid E Gerber

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-03

View on ClinicalTrials.gov More KRAS Gene Mutation trials