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Clinical Trials in Australia / NCT07700160
Recruiting Phase 1/2

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

NCT07700160 · tracked via the Priya Life Science Australia tracker
Sponsor
VelaVigo Bio Inc
Phase
Phase 1/2
Started
2026-07-30
Last updated
2026-09-01

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

VBC108

VBC108: VBC108

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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: 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.

Primary outcome measure(s)

  • Incidence of dose-limiting toxicities (DLT) as defined in the protocol — From time of first dose of VBC108 to end of DLT period ( 21 days)
    Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
  • Incidence of Serious Adverse Events — From time of Informed Consent to 30 days post last dose of VBC108
    Number of patients with serious adverse events by system organ class and preferred term
  • Incidence of Adverse Events (AEs) — From time of Informed Consent to 30 days post last dose of VBC108
    Number of patients with adverse events by system organ class and preferred term
  • Objective Response Rate (ORR) — From first dose of VBC108 to disease progression or death, up to approximately 2 years
    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)

Trial sites (12)

FacilityCityRegionStatus
City of Hope Medical Center Duarte California Recruiting
START Midwest, LLC Grand Rapids Michigan Recruiting
Laura and Issac Perlmutter Cancer Center New York New York Not Yet Recruiting
Next Oncology - Oncology San Antonio Texas Recruiting
NEXT Oncology Virginia Fairfax Virginia Recruiting
GenesisCare North Shore St Leonards New South Wales Recruiting
One Clinical Research Perth Western Australia Not Yet Recruiting
Beijing Cancer Hospital Beijing Beijing Municipality Not Yet Recruiting
Beijing GoBroad Hospital Beijing Beijing Municipality Not Yet Recruiting
Zhongshan Hospital Shanghai Shanghai Municipality Not Yet Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Not Yet Recruiting
Zhejiang Cancer Hospital Hangzhou Zhejiang Not Yet Recruiting

More VelaVigo Bio Inc trials in Australia

First-in-Human Trial of VBC106 in Participants With Advanced Solid Tumors Starting soon
VBC117First-in-Human Trial of VBC117 in Participants With Advanced Malignant Solid Tumors Starting soon

Other trials for the same condition

EIK1005-002: A Clinical Research Study Evaluating EIK1005, a Werner Helicase Inhibitor, as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors Including Microsatellite Instability High (MSI-H) Tumors Recruiting
A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors Recruiting
Study of BPI-572270 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors Recruiting
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07700160 on ClinicalTrials.gov ↗ ← All trials in Australia