First-in-Human Trial of VBC108 in Participants With Advanced Malignant Solid Tumors (NCT07700160) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
First-in-Human Trial of VBC108 in Participants With Advanced Malignant Solid Tumors
United States, Australia, China230 participantsStarted 2026-07-13
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The participant or the participant's legally acceptable representative is willing and able to provide a written ICF before initiating any trial procedure.
. Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor .
. At least one measurable lesion as assessed by the investigator according to RECIST v1.1 criteria.
. Male or female adults (defined as ≥ 18 years of age).
. ECOG performance status 0-1.
. Life expectancy greater than 12 weeks.
. Archived tumor tissue sample available or able to undergo a fresh biopsy collection.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Timeframe: From time of first dose of VBC108 to end of DLT period ( 21 days)
2
Incidence of Serious Adverse Events
Timeframe: From time of Informed Consent to 30 days post last dose of VBC108
3
Incidence of Adverse Events (AEs)
Timeframe: From time of Informed Consent to 30 days post last dose of VBC108
4
Objective Response Rate (ORR)
Timeframe: From first dose of VBC108 to disease progression or death, up to approximately 2 years