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

PHASE 1/2A OPEN-LABEL CLINICAL TRIAL EVALUATING VBC101, AN EGFR AND CMET TARGETED BI-SPECIFIC ANTIBODY DRUG CONJUGATE, IN PARTICIPANTS WITH ADVANCED SOLID TUMOR MALIGNANCIES

This trial will try the experimental drug VBC101 in adults with advanced solid tumors that have progressed after standard treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 310 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: VelaVigo Bio Inc (Industry-sponsored)
• Drugs / interventions: radiation, prednisone
• Locations: 5 sites (Grand Rapids, Michigan and 4 other locations)
• Trial ID: NCT07136779 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with unresectable or metastatic solid tumors that have progressed after or are intolerant of standard treatments, with at least one measurable lesion, ECOG 0-1, adequate organ and bone marrow function, LVEF ≥50%, and available tumor tissue are the ideal candidates.

Not a fit: Patients with good treatment options from standard therapies, ECOG performance status ≥2, significant cardiac impairment (LVEF <50%), or those unwilling/unable to provide tumor tissue or consent are unlikely to benefit from this first-in-human trial.

Why it matters

Potential benefit: If successful, VBC101 could offer a new treatment option that shrinks tumors or slows disease progression for some patients with advanced solid cancers.

How similar studies have performed: There are no prior clinical data for VBC101 specifically; first-in-human trials of other novel oncology agents have sometimes shown promising activity but results are variable and uncertain.

Eligibility criteria

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 this trial is running

Grand Rapids, Michigan and 4 other locations

• 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

Conditions Participants With Advanced Solid Tumor Malignancies