First-in-Human Trial of VBC106 in Participants With Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
VBC106: VBC106
Study summary
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion adopts BOIN design to identify 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 VBC106.
Eligibility
Primary outcome measure(s)
- Incidence of dose-limiting toxicities (DLT) as defined in the protocol — (DLT)From time of first dose of VBC106 to end of DLT period (approximately 21 days)
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol - Incidence of Serious Adverse Events — From time of Informed Consent to 30 days post last dose of VBC106
Number of patients with serious adverse events by system organ class and preferred term - Incidence of Adverse Events (AEs) — From time of Informed Consent to 30 days post last dose of VBC106
Number of patients with adverse events by system organ class and preferred term
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| NEXT Oncology Houston | Houston | Texas | |
| START Mountain Region, LLC. | West Valley City | Utah | |
| NEXT Oncology Virginia | Fairfax | Virginia | |
| Icon Cancer Centre Wesley | Brisbane | Queensland |
More VelaVigo Bio Inc trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07686068 on ClinicalTrials.gov ↗ ← All trials in Australia