First-in-Human Study of VBC101 for Advanced Solid Tumors

Inclusion Criteria

• Must be willing and able to provide written consent to participate.
• Have a confirmed diagnosis of advanced or metastatic solid tumor that cannot be surgically removed and has worsened after standard treatments, or for which no standard treatment is available.
• Have at least one tumor that can be measured by scans.
• Be an adult aged 18 or older.
• Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have a heart function of at least 50% as measured by specific tests.
• Have a life expectancy of more than 12 weeks.
• Have a previous tumor sample available or be willing to undergo a new biopsy.
• Have adequate organ and bone marrow function.
• Meet the required time period since the last cancer treatment before starting the study drug.

Exclusion Criteria

• Have unresolved side effects from previous cancer treatments, except for hair loss, nerve damage, or skin color changes. Stable, chronic side effects may be allowed with agreement from the study doctor.
• Have untreated or unstable brain or spinal cord tumors unless they have been treated and are stable without needing increasing doses of steroids or anti-seizure medications.
• Have previously received treatments targeting EGFR and/or cMet, including VBC101.
• Have previously received treatments with a specific type of drug called ADC carrying a TOP1i payload, including VBC101.
• Have a history of certain lung diseases or currently have these diseases as shown by imaging tests.