First-in-human testing of VBC101 in advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, multiple-dose Phase 1/2a first-in-human trial of VBC101. The Phase 1 portion uses an accelerated titration for the initial dose level followed by a Bayesian Optimal Interval (BOIN) design to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), with potential backfill cohorts. The Phase 2a portion performs dose optimization and then cohort expansion to confirm safety and tolerability and to further evaluate efficacy of the selected RP2D in selected solid tumor types. Eligible participants are adults with unresectable or metastatic solid tumors that have relapsed or progressed after standard therapy, have measurable disease, adequate organ function, and available tumor tissue for testing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

A participant must meet all of the following inclusion criteria to be eligible to participate in this trial:

* 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 Criteria:

1\. Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment, except for alopecia, neuropathy, or skin pigmentation changes. Participants with chronic but stable Grade 2 toxicities may be allowed to enroll after agreement between the study investigator and the Sponsor's Medical Monitor.

* 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.

Where it's running

• Start Midwest
  Grand Rapids, Michigan, United States Recruiting
• The University of Texas MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• NEXT Oncology
  San Antonio, Texas, United States Recruiting
• START Mountain Region, LLC.
  West Valley City, Utah, United States Recruiting
• NEXT Virginia
  Fairfax, Virginia, United States Recruiting

Study contacts

• Study coordinator: Chen Li
• Email: chen.li@velavigo.com
• Phone: +86 13681943496

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• VBC103 treatment for advanced malignant solid tumors

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  Recruiting Phase 1/2 VelaVigo Bio Inc · Shanghai, Shanghai Municipality · NCT07299747

• First-in-Human Trial of a VBC108 Treatment for Advanced Solid Tumors

  This early-stage trial tests VBC108 in adults with unresectable or metastatic solid tumors to see if it is safe and tolerable and to get a sense of how well it might work.

  Recruiting at 5 sites Phase 1/2 VelaVigo Bio Inc · Duarte, California and 11 other locations · NCT07700160

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.