First-in-Human Trial of VBC101 in Participants With Advanced Solid Tumor Malignancies

Protocol Version：V1.3 Version Date：2026-04-20

Inclusion criteria

A participant must meet all of the following inclusion criteria to be eligible to participate in this trial:

• 1. The participant or the participant's legally acceptable representative is willing and able to provide a written ICF before initiating any trial procedure.
• 2. Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or is intolerable with standard treatment, or for which no standard treatment is available
• 3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1criteria
• 4. Male or female adults (defined as ≥ 18 years of age)
• 5. ECOG performance status 0-1
• 6. Has LVEF ≥ 50% by either ECHO or MUGA within 28 days before enrollment.
• 7. Life expectancy greater than 12 weeks
• 8. Archived tumor tissue sample available or able to undergo a fresh biopsy collection.
• 9. Adequate organ and bone marrow function
• 10. Participants must meet the minimum washout period requirements before the first dose of investigational drug

Exclusion criteria

• Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment, except for alopecia, neuropathy, or skin pigmentation changes. Participants with chronic but stable Grade 2 toxicities may be allowed to enroll after agreement between the study investigator and the Sponsor's Medical Monitor.

• 2. Known or suspected brain metastases, or spinal cord compression, unless the condition has been treated, asymptomatic, and has been stable without requiring escalating doses of corticosteroids (equivalent to ≤10 mg/day prednisone) or anti-convulsant medications for at least four weeks prior for the first dose of investigational drug.
• 3. Prior treatment with an ADC targeting EGFR and/or cMet (including VBC101)
• 4. Prior treatment with any ADC carrying a TOP1i payload (including prior VBC101).
• 5. Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.