First-in-Human Trial of VBC101 in Participants With Advanced Solid Tumor Malignancies
NCT ID: NCT07136779
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
310 participants
INTERVENTIONAL
2025-09-23
2028-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase 1 (Dose Escalation and Backfill)，Phase 2（Dose optimization and Cohort Expansion）
VBC101
VBC101
Interventions
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VBC101
VBC101
Eligibility Criteria
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Inclusion Criteria
* 2\. Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or is intolerable with standard treatment, or for which no standard treatment is available
* 3\. At least one measurable lesion as assessed by the investigator according to RECIST v1.1criteria
* 4\. Male or female adults (defined as ≥ 18 years of age)
* 5\. ECOG performance status 0-1
* 6\. Has LVEF ≥ 50% by either ECHO or MUGA within 28 days before enrollment.
* 7\. Life expectancy greater than 12 weeks
* 8\. Archived tumor tissue sample available or able to undergo a fresh biopsy collection.
* 9\. Adequate organ and bone marrow function
* 10\. Participants must meet the minimum washout period requirements before the first dose of investigational drug
Exclusion Criteria
* 2\. Known or suspected brain metastases, or spinal cord compression, unless the condition has been treated, asymptomatic, and has been stable without requiring escalating doses of corticosteroids (equivalent to ≤10 mg/day prednisone) or anti-convulsant medications for at least four weeks prior for the first dose of investigational drug.
* 3\. Prior treatment with an ADC targeting EGFR and/or cMet (including VBC101)
* 4\. Prior treatment with any ADC carrying a TOP1i payload (including prior VBC101).
* 5\. Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.
18 Years
ALL
No
Sponsors
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VelaVigo Bio Inc
INDUSTRY
Responsible Party
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Locations
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Start Midwest
Grand Rapids, Michigan, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
START Mountain Region, LLC.
West Valley City, Utah, United States
NEXT Virginia
Fairfax, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VBC101-01-01
Identifier Type: -
Identifier Source: org_study_id
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