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First-in-Human Trial of VBC101 for Advanced Solid Tumor Malignancies

This study is a first-in-human trial testing a drug called VBC101 in people with advanced solid tumor malignancies (cancers that have spread). The main goals are to find a safe dose of VBC101 and to see how well it is tolerated. Researchers will be looking for any serious side effects or other problems that might limit the dose. You may be able to join if you are 18 years or older and have an advanced solid tumor. The study is currently unclear on its recruitment status and plans to enroll up to 310 participants.

Study design
This is a multi-center, open-label (everyone knows what treatment is being given), multiple-dose study with two parts, Phase 1 and Phase 2a. It plans to enroll up to 310 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for serious side effects from the time you agree to participate until 30 days after your last dose of VBC101.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07136779

First-in-Human Trial of VBC101 in Participants With Advanced Solid Tumor Malignancies

Recruiting
PHASE1Ages 18+InterventionalTreatment
VelaVigo Bio Inc
~310 participants
Updated 2026-09-03 on ClinicalTrials.gov
What's tested:VBC101

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Measured over (DLT)From time of first dose of VBC101 to end of DLT period (approximately 21 days)
+2 more outcomes measured

Conditions

Participants With Advanced Solid Tumor Malignancies

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NCT07136779

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • NEXT Oncology

    San Antonio, Texasstudy coordinator listed

    Recruiting

  • NEXT Virginia

    Fairfax, Virginiastudy coordinator listed

    Recruiting

  • Start Midwest

    Grand Rapids, Michiganstudy coordinator listed

    Recruiting

  • START Mountain Region, LLC.

    West Valley City, Utahstudy coordinator listed

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Chen Li
[email protected]
+86 13681943496
Email the study team

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Eligibility criteria

Inclusion

1\. The participant or the participant's legally acceptable representative is willing and able to provide a written ICF before initiating any trial procedure.
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

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.

What this trial measures

  • Incidence of dose-limiting toxicities (DLT) as defined in the protocol(DLT)From time of first dose of VBC101 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 EventsFrom time of Informed Consent to 30 days post last dose of VBC101

    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 VBC101

    Number of patients with adverse events by system organ class and preferred term