First-in-Human Trial of VBC106 in Participants With Advanced Solid Tumors

Part of paid clinical trials in Houston, Texas.

Sponsor
VelaVigo Bio Inc
Study ID
NCT07686068
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Participants With Advanced Solid Tumor Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VBC106 — DRUG
    VBC106

Study Details

This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion adopts 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 VBC106.

Key Dates

Start date
Aug 18, 2026
Status verified
Jun 2026
Primary completion
Dec 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
260 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 (Dose Escalation and Backfill),Phase 2(Dose optimization and Cohort Expansion)

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLT) as defined in the protocol [ Time Frame: (DLT)From time of first dose of VBC106 to end of DLT period (approximately 21 days) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
NEXT Oncology HoustonHoustonTexas77054
Jennifer Segar
+1 (832) 384-7900
START Mountain Region, LLC.West Valley CityUtah84119
Jose Pacheco
+1 (801) 907-4750
NEXT Oncology VirginiaFairfaxVirginia22031
Mohamad Salkeni
+1 (703) 783-4510

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