First-in-Human Trial of VBC108 in Participants With Advanced Malignant Solid Tumors
Phase 1/2a Open-label Clinical Trial Evaluating VBC108, a CLDN18.2 and CDH17-directed Bi-specific Antibody Drug Conjugate, in Participants With Advanced Malignant Solid Tumors
1 other identifier
interventional
230
3 countries
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2026
Typical duration for phase_1
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2026
CompletedFirst Posted
Study publicly available on registry
July 13, 2026
CompletedStudy Start
First participant enrolled
July 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 17, 2029
July 13, 2026
July 1, 2026
3 years
July 7, 2026
July 7, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
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
From time of first dose of VBC108 to end of DLT period ( 21 days)
Incidence of Serious Adverse Events
Number of patients with serious adverse events by system organ class and preferred term
From time of Informed Consent to 30 days post last dose of VBC108
Incidence of Adverse Events (AEs)
Number of patients with adverse events by system organ class and preferred term
From time of Informed Consent to 30 days post last dose of VBC108
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)
From first dose of VBC108 to disease progression or death, up to approximately 2 years
Study Arms (6)
VBC108 Dose Level 1
EXPERIMENTALPhase 1 dose escalation and backfill: VBC108 at Dose Level 1
VBC108 Dose Level 2
EXPERIMENTALPhase 1 dose escalation and backfill: VBC108 at Dose Level 2
VBC108 Dose Level 3
EXPERIMENTALPhase 1 dose escalation and backfill: VBC108 at Dose Level 3
VBC108 Dose Level 4
EXPERIMENTALPhase 1 dose escalation and backfill: VBC108 at Dose Level 4
VBC108 Dose Level 5
EXPERIMENTALPhase 1 dose escalation and backfill: VBC108 at Dose Level 5
VBC108 Dose Level recommended Phase 2 dose (RP2D)
EXPERIMENTALPhase 2a expansion cohort: VBC108 at recommended Phase 2 dose (RP2D) across tumor-specific cohorts
Interventions
VBC108
Eligibility Criteria
You may qualify if:
- The participant or the participant's legally acceptable representative is willing and able to provide a written ICF before initiating any trial procedure.
- Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor .
- At least one measurable lesion as assessed by the investigator according to RECIST v1.1 criteria.
- Male or female adults (defined as ≥ 18 years of age).
- ECOG performance status 0-1.
- Life expectancy greater than 12 weeks.
- Archived tumor tissue sample available or able to undergo a fresh biopsy collection.
- Adequate organ and bone marrow function.
- Participants must meet the minimum washout period requirements before the first dose of investigational drug.
You may not qualify if:
- Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment.
- Known or suspected brain metastases, or spinal cord compression.
- Prior treatment with an ADC targeting CLDN18.2x CDH17 bispecific ADC.
- Prior treatment with any ADC carrying a topoisomerase I inhibitor (TOP1i) payload.
- Prior treatment with CLDN18.2 targeting CAR-T.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VelaVigo Bio Inclead
Study Sites (12)
City of Hope Medical Center
Duarte, California, 91010, United States
START Midwest, LLC
Grand Rapids, Michigan, 49546, United States
Laura and Issac Perlmutter Cancer Center
New York, New York, 10016, United States
Next Oncology - Oncology
San Antonio, Texas, 78229, United States
NEXT Oncology Virginia
Fairfax, Virginia, 22031, United States
GenesisCare North Shore
St Leonards, New South Wales, 2065, Australia
One Clinical Research
Perth, Western Australia, 6009, Australia
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Beijing GoBroad Hospital
Beijing, Beijing Municipality, 102200, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2026
First Posted
July 13, 2026
Study Start
July 13, 2026
Primary Completion (Estimated)
July 7, 2029
Study Completion (Estimated)
September 17, 2029
Last Updated
July 13, 2026
Record last verified: 2026-07