VelaVigo Bio Inc
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion uses Bayesian optimal interval (BOIN) design to escalate and determine the MTD and/or RP2D with potential backfill cohorts. The Phase 2a portion consists of dose optimization followed by cohort expansion to confirm safety and tolerability and to further evaluate the efficacy of the selected RP2D in selected solid tumor malignancies for VBC108.
Inclusion Criteria: 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 . 3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1 criteria. 4. Male or female adults (defined as ≥ 18 years of age). 5. ECOG performance status 0-1. 6. Life expectancy greater than 12 weeks. 7. Archived tumor tissue sample available or able to undergo a fresh biopsy collection. 8. Adequa…
VBC108