First-in-Human Trial of VERT-002 for Patients with Advanced Solid Tumors with MET Changes

Inclusion Criteria

• Have a confirmed diagnosis of advanced solid tumor that has returned or is resistant to treatment, with no other standard treatment options available.
• For Part 2, have advanced non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation.
• Have specific changes in the MET gene, such as METex14 mutation or MET amplification, confirmed by local testing.
• Have at least one measurable tumor according to standard criteria.
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• For Part 1, may have previously received MET Tyrosine Kinase Inhibitor (TKI) treatment.
• For Part 2, have received no more than two prior lines of systemic therapy.
• Have adequate blood, liver, and kidney function.
• Have a blood protein level (albumin) of at least 3 g/dL.
• Have normal blood clotting and heart function.
• Women of childbearing potential must have a negative pregnancy test before starting the study and agree to use effective contraception.
• Men must agree to use contraception to prevent pregnancy in their partners.

Exclusion Criteria

• Have other targetable gene mutations that can be treated with different drugs.
• Have had another type of cancer, unless it was treated at least two years ago and there is no evidence of it now.
• Have uncontrolled brain or spinal cord tumors causing symptoms or needing increasing steroid doses.
• Have allergies to VERT-002 or similar drugs.
• Have active infections or tested positive for COVID-19 within two weeks before starting the study.
• Have significant heart problems or other serious medical conditions.
• Have a history of lung diseases like interstitial lung disease or radiation pneumonitis.
• Are pregnant or breastfeeding.
• Have received MET TKI treatment within seven days before starting the study.
• Have had other cancer treatments within a certain timeframe before starting the study.
• Have received a live vaccine within 28 days before starting the study.
• Have unresolved side effects from previous treatments, except for mild hair loss, fatigue, or mild nerve damage.
• Have had major surgery within 14 days before starting the study.
• Have participated in another clinical trial with an investigational drug within a certain timeframe before starting the study.