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RecruitingNCT07700160Updated Sep 1, 2026

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

A Phase 1/2 interventional study of VBC108 in Advanced Solid Tumors, sponsored by VelaVigo Bio Inc. Recruiting at 12 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by VelaVigo Bio Inc · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 2 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
230
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Advanced Solid Tumors
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In context

Lead sponsor

VelaVigo Bio Inc is the lead sponsor of 5 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  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 .
  3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1 criteria.
  4. Male or female adults (defined as ≥ 18 years of age).
  5. ECOG performance status 0-1.
  6. Life expectancy greater than 12 weeks.
  7. Archived tumor tissue sample available or able to undergo a fresh biopsy collection.
  8. Adequate organ and bone marrow function.
  9. Participants must meet the minimum washout period requirements before the first dose of investigational drug.

Exclusion criteria

Exclusion Criteria:

  1. Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment.
  2. Known or suspected brain metastases, or spinal cord compression.
  3. Prior treatment with an ADC targeting CLDN18.2x CDH17 bispecific ADC.
  4. Prior treatment with any ADC carrying a topoisomerase I inhibitor (TOP1i) payload.
  5. Prior treatment with CLDN18.2 targeting CAR-T.
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
230 participants (estimated)

Study arms

  • Experimental
    VBC108 Dose Level 1

    Phase 1 dose escalation and backfill: VBC108 at Dose Level 1

    Drug: VBC108

  • Experimental
    VBC108 Dose Level 2

    Phase 1 dose escalation and backfill: VBC108 at Dose Level 2

    Drug: VBC108

  • Experimental
    VBC108 Dose Level 3

    Phase 1 dose escalation and backfill: VBC108 at Dose Level 3

    Drug: VBC108

  • Experimental
    VBC108 Dose Level 4

    Phase 1 dose escalation and backfill: VBC108 at Dose Level 4

    Drug: VBC108

  • Experimental
    VBC108 Dose Level 5

    Phase 1 dose escalation and backfill: VBC108 at Dose Level 5

    Drug: VBC108

  • Experimental
    VBC108 Dose Level recommended Phase 2 dose (RP2D)

    Phase 2a expansion cohort: VBC108 at recommended Phase 2 dose (RP2D) across tumor-specific cohorts

    Drug: VBC108

Interventions

  • DrugVBC108

    VBC108

06

What researchers measure

Primary outcomes

  1. Incidence of dose-limiting toxicities (DLT) as defined in the protocol

    Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol

    Time frame: From time of first dose of VBC108 to end of DLT period ( 21 days)

  2. Incidence of Serious Adverse Events

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

    Time frame: From time of Informed Consent to 30 days post last dose of VBC108

  3. Incidence of Adverse Events (AEs)

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

    Time frame: From time of Informed Consent to 30 days post last dose of VBC108

  4. Objective Response Rate (ORR)

    The percentage or number of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST v1.1)

    Time frame: From first dose of VBC108 to disease progression or death, up to approximately 2 years

07

Study locations

5 of 12 sites recruiting
  • City of Hope Medical Center
    Duarte, California 91010, United States
    Recruiting
  • START Midwest, LLC
    Grand Rapids, Michigan 49546, United States
    Recruiting
  • Laura and Issac Perlmutter Cancer Center
    New York, New York 10016, United States
    Not yet recruiting
  • Next Oncology - Oncology
    San Antonio, Texas 78229, United States
    Recruiting
  • NEXT Oncology Virginia
    Fairfax, Virginia 22031, United States
    Recruiting
  • GenesisCare North Shore
    St Leonards, New South Wales 2065, Australia
    Recruiting
  • One Clinical Research
    Perth, Western Australia 6009, Australia
    Not yet recruiting
  • Beijing Cancer Hospital
    Beijing, Beijing Municipality 100142, China
    Not yet recruiting
  • Beijing GoBroad Hospital
    Beijing, Beijing Municipality 102200, China
    Not yet recruiting
  • Zhongshan Hospital
    Shanghai, Shanghai Municipality 200032, China
    Not yet recruiting
  • The First Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310009, China
    Not yet recruiting
  • Zhejiang Cancer Hospital
    Hangzhou, Zhejiang 310022, China
    Not yet recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07700160
Lead sponsor
VelaVigo Bio Inc
Responsible party
Sponsor
First posted
Jul 13, 2026
Start date
Jul 30, 2026
Primary completion
Jul 7, 2029 (estimated)
Completion
Sep 17, 2029 (estimated)
Last update
Sep 1, 2026

Study contacts

Jun Yan
Contact
jun.yan@VelaVigo.com
15800359085

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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