First-in-Human Trial of VBC108 in Participants With Advanced Malignant Solid Tumors

Part of paid clinical trials in Duarte, California.

Sponsor
VelaVigo Bio Inc
Study ID
NCT07700160
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

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

Interventions

  • VBC108 — DRUG
    VBC108

Study Details

This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion uses Bayesian optimal interval (BOIN) design to escalate and determine 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 VBC108.

Key Dates

First listed
Jul 13, 2026
Start date
Jul 13, 2026
Status verified
Jul 2026
Primary completion
Jul 7, 2029
Completion
Sep 17, 2029

Study Design

Enrollment
230 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: VBC108 Dose Level 1
    Phase 1 dose escalation and backfill: VBC108 at Dose Level 1
  • Experimental: VBC108 Dose Level 2
    Phase 1 dose escalation and backfill: VBC108 at Dose Level 2
  • Experimental: VBC108 Dose Level 3
    Phase 1 dose escalation and backfill: VBC108 at Dose Level 3
  • Experimental: VBC108 Dose Level 4
    Phase 1 dose escalation and backfill: VBC108 at Dose Level 4
  • Experimental: VBC108 Dose Level 5
    Phase 1 dose escalation and backfill: VBC108 at Dose Level 5
  • Experimental: VBC108 Dose Level recommended Phase 2 dose (RP2D)
    Phase 2a expansion cohort: VBC108 at recommended Phase 2 dose (RP2D) across tumor-specific cohorts

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLT) as defined in the protocol [ Time Frame: From time of first dose of VBC108 to end of DLT period ( 21 days) ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Dani Castillo, MD
[email protected]
6262182123
START Midwest, LLCGrand RapidsMichigan49546
Sreenivasa Chandana
[email protected]
16169545554
Laura and Issac Perlmutter Cancer CenterNew YorkNew York10016
Paul Oberstein
[email protected]
12123050592
Next Oncology - OncologySan AntonioTexas78229
David Sommerhalder
[email protected]
2105809500
NEXT Oncology VirginiaFairfaxVirginia22031
Mohamad Salkeni
[email protected]
7032083159

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CASTART Midwest, LLC· Grand Rapids, MILaura and Issac Perlmutter Cancer Center· New York, NYNext Oncology - Oncology· San Antonio, TXNEXT Oncology Virginia· Fairfax, VA

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