Actively Recruiting
First-in-Human Trial of VBC101 in Participants With Advanced Solid Tumor Malignancies
Led by VelaVigo Bio Inc · Updated on 2026-04-22
310
Participants Needed
5
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion adopts an accelerated titration for the first dose level, followed by 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 VBC101.
CONDITIONS
Official Title
First-in-Human Trial of VBC101 in Participants With Advanced Solid Tumor Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent before starting any trial procedures
- Histologically or cytologically confirmed unresectable advanced or metastatic solid tumor that has relapsed or progressed after standard treatments, is intolerable with standard treatment, or has no standard treatment available
- At least one measurable lesion according to RECIST v1.1 criteria
- Male or female adults aged 18 years or older
- ECOG performance status of 0 or 1
- Left ventricular ejection fraction (LVEF) of 50% or higher by ECHO or MUGA within 28 days before enrollment
- Life expectancy greater than 12 weeks
- Archived tumor tissue sample available or able to undergo fresh biopsy collection
- Adequate organ and bone marrow function
- Meet minimum washout period requirements before first dose of investigational drug
You will not qualify if you...
- Any unresolved toxicity of Grade 2 or higher from previous anti-cancer treatment, except alopecia, neuropathy, or skin pigmentation changes, unless stable and agreed upon by investigator and Medical Monitor
- Known or suspected brain metastases or spinal cord compression unless treated, asymptomatic, stable, and no need for escalating corticosteroids or anti-convulsants for at least 4 weeks prior to first dose
- Prior treatment with an antibody drug conjugate targeting EGFR and/or cMet including VBC101
- Prior treatment with any antibody drug conjugate carrying a TOP1i payload including VBC101
- Medical history or current diagnosis of interstitial lung diseases or suspected by imaging at screening
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Start Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
2
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
3
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
4
START Mountain Region, LLC.
West Valley City, Utah, United States, 84119
Actively Recruiting
5
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
C
Chen Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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