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NCT Number: NCT07686068

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

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.

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Key information

Conditions

Participants With Advanced Solid Tumor Malignancies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Icon Cancer Centre Wesley, Brisbane, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - A participant must meet all of the following inclusion criteria to be eligible to participate in this trial:
  • 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 that has relapsed or progressed on or after standard systemic treatments, or is intolerable with standard treatment, or standard therapies are not appropriate or not safe in the opinion of the Investigator or refused by the participant.
  • 3. At least one measurable lesion as assessed according to RECIST v1.1 criteria for participants with non-pleural mesothelioma or other solid tumors and modified RECIST(mRECIST) for participants with malignant pleural mesothelioma.
  • 4. Male or female adults (defined as ≥ 18 years of age)
  • 5. ECOG performance status 0-1
  • 6. Has LVEF ≥ 50% by either ECHO or MUGA within 28 days before enrollment.
  • 7. Life expectancy greater than 12 weeks
  • 8. Archived tumor tissue sample available or able to undergo a fresh biopsy collection.
  • 9. Adequate organ and bone marrow function

Exclusion criteria

  • Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment.
  • Known or suspected brain metastases, or spinal cord compression.
  • Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.
  • Has a history of underlying pulmonary disorder including.
  • History of chronic, active, or hereditary corneal disease.
  • Participant history of congestive heart failure (CHF) Class II-IV according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment.

Treatment and study plan

VBC106

Drug

VBC106

Primary outcomes

  1. 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)

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

  2. Incidence of Serious Adverse Events

    Time frame: From time of Informed Consent to 30 days post last dose of VBC106

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

  3. Incidence of Adverse Events (AEs)

    Time frame: From time of Informed Consent to 30 days post last dose of VBC106

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

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: From date of first dose of VBC106 up until progression, or the last evaluable assessment in the absence of progression (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)

  2. Duration of Response (DoR)

    Time frame: From date of first dose of VBC106 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)

    The time from date of first response until date of disease progression or last evaluable assessment (RECIST v1.1) in the absence of progression

  3. Disease Control Rate (DCR) at 12 weeks

    Time frame: From date of first dose of VBC106 up until progression, or the last evaluable assessment in the absence of progression (for each patient this is expected to be measured at 12 weeks)

    The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1) for >=11 weeks from first dose

  4. Progression free Survival (PFS)

    Time frame: From date of first dose of VBC106 up until date of progression or death due to any cause (approximately 2 years)

    The time from first dose until RECIST 1.1 defined disease progression or death due to any cause

  5. Overall Survival (OS)

    Time frame: From date of first dose of VBC106 up until the date of death due to any cause (approximately 2 years)

    The time from the date of the first dose of study treatment until death due to any cause.

  6. Pharmacokinetics of VBC106

    Time frame: From date of first dose of VBC106 up until 30 days post last dose

    Measurement of plasma concentrations of VBC106, total antibody and total unconjugated warhead(measurement unit can be same as ng/ml)

  7. Pharmacokinetics of VBC106: Area under the concentration time curve (AUC)

    Time frame: From date of first dose of VBC106 up until 30 days post last dose

    Measurement of PK parameters: Area under the concentration time curve (AUC)

  8. Pharmacokinetics of VBC106: Maximum plasma concentration of the study drug (C-max)

    Time frame: From date of first dose of VBC106 up until 30 days post last dose

    Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max)

  9. Pharmacokinetics of VBC106: Time to maximum plasma concentration of the study drug (T-max)

    Time frame: From date of first dose of VBC106 up until 30 days post last dose

    Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max)

  10. Pharmacokinetics of VBC106: Half-life

    Time frame: From date of first dose of VBC106 up until 30 days post last dose

    Measurement of PK parameters: Terminal elimination half-life (t 1/2)

  11. Immunogenicity of VBC106: Anti-Drug Antibodies (ADA)

    Time frame: From date of first dose of VBC106 up until 30 days post last dose

    Evaluating the number and percentage of patients who develop Anti-drug antibody (ADA) during treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Guo

CONTACT

[email protected]

17368707951

Sponsors and collaborators

Lead sponsor

VelaVigo Bio Inc

Industry

Registry information

Official study title

Phase 1/2a Open-Label Clinical Trial Evaluating VBC106, an FRα- and MSLN-Directed Bispecific Antibody Drug Conjugate, in Participants With Advanced Malignant Solid Tumors

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 7, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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