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

June 30, 2026 updated by: VelaVigo Bio Inc

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

260

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4066
        • Icon Cancer Centre Wesley
        • Contact:
  • United States
    • Texas
      • Houston, Texas, United States, 77054
    • Utah
      • West Valley City, Utah, United States, 84119
    • Virginia
      • Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  1. Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment.
  2. Known or suspected brain metastases, or spinal cord compression.
  3. 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.
  4. Has a history of underlying pulmonary disorder including.
  5. History of chronic, active, or hereditary corneal disease.
  6. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1 (Dose Escalation and Backfill)，Phase 2（Dose optimization and Cohort Expansion）
Drug: VBC106
VBC106

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
(DLT)From time of first dose of VBC106 to end of DLT period (approximately 21 days)
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
From time of Informed Consent to 30 days post last dose of VBC106
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
From time of Informed Consent to 30 days post last dose of VBC106

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From date of first dose of VBC106 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
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
From date of first dose of VBC106 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
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
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)
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
From date of first dose of VBC106 up until date of progression or death due to any cause (approximately 2 years)
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.
From date of first dose of VBC106 up until the date of death due to any cause (approximately 2 years)
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
From date of first dose of VBC106 up until 30 days post last dose
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)
From date of first dose of VBC106 up until 30 days post last dose
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)
From date of first dose of VBC106 up until 30 days post last dose
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)
From date of first dose of VBC106 up until 30 days post last dose
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)
From date of first dose of VBC106 up until 30 days post last dose
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
From date of first dose of VBC106 up until 30 days post last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VelaVigo Bio Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 18, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

June 30, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • VBC106-01-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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