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NCT07136779 · ClinicalTrials.gov registry record · Phase 1
First-in-Human Trial of VBC101 in Participants With Advanced Solid Tumor Malignancies
A Phase 1 study of Participants With Advanced Solid Tumor Malignancies, sponsored by VelaVigo Bio.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 310
- Enrollment target
- 5
- Study locations
NCT07136779: Recruiting Phase 1 study of Participants With Advanced Solid Tumor Malignancies, sponsored by VelaVigo Bio.
NCT07136779 is a Phase 1 study of Participants With Advanced Solid Tumor Malignancies that is actively recruiting participants, run by VelaVigo Bio. The registered enrollment target is 310 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (417% higher). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07136779, a Phase 1 study of Participants With Advanced Solid Tumor Malignancies, is actively recruiting participants, sponsored by VelaVigo Bio.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 310 participants
- Enrollment target
- 5
- Study locations
Study Summary
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.
Primary Outcome
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Conditions Studied
Interventions
- DRUG VBC101
Study Locations (5)
Texas
- The University of Texas MD Anderson Cancer Center - Houston
- NEXT Oncology - San Antonio
Michigan
- Start Midwest - Grand Rapids
Utah
- START Mountain Region, LLC. - West Valley City
Virginia
- NEXT Virginia - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 2025-09-23 |
| Est. Completion | 2028-07-01 |
| Phase | Phase 1 |
What NCT07136779 shows while recruiting
NCT07136779 is an interventional study that assigns participants to a tested intervention. The registered 310 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (417% higher).
The record links to 1 condition, with Participants With Advanced Solid Tumor Malignancies appearing as the primary indexed condition, and to 1 intervention - of which VBC101 is the first listed.
NCT07136779 lists 5 locations in 4 states (Texas, Michigan, Utah).
Frequently Asked Questions
What is clinical trial NCT07136779 about?
NCT07136779 is a clinical study titled "First-in-Human Trial of VBC101 in Participants With Advanced Solid Tumor Malignancies". 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 b...
What is the current status of trial NCT07136779?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 310 participants. The study started on 2025-09-23. Estimated completion is 2028-07-01.
What conditions does trial NCT07136779 study?
This clinical trial studies the following conditions: Participants With Advanced Solid Tumor Malignancies.
What interventions are being tested in trial NCT07136779?
The interventions under investigation include: VBC101 (DRUG).
Who is sponsoring clinical trial NCT07136779?
This trial is sponsored by VelaVigo Bio, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07136779 being conducted?
This trial has 5 study locations across Michigan, Texas, Utah, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07136779's enrollment target sits among peer trials
310 120th of 2000 higher than 1,879 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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