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Not yet recruitingNCT07686068Updated Jul 9, 2026

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

A Phase 1/2 interventional study of VBC106 in Participants With Advanced Solid Tumor Malignancies, sponsored by VelaVigo Bio Inc. Not yet recruiting at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.

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

Phase
Phase 1/2
Study type
Interventional
Enrollment
260
Allocation
Not applicable
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 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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Conditions studied

  • Participants With Advanced Solid Tumor Malignancies
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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

  • - 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

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.
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
260 participants (estimated)

Study arms

  • Experimental
    Phase 1 (Dose Escalation and Backfill),Phase 2(Dose optimization and Cohort Expansion)

    Drug: VBC106

Interventions

  • DrugVBC106

    VBC106

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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: (DLT)From time of first dose of VBC106 to end of DLT period (approximately 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 VBC106

  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 VBC106

Secondary outcomes

  1. 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 date of first dose of VBC106 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)

  2. Duration of Response (DoR)

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

    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)

  3. Disease Control Rate (DCR) 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

    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)

  4. Progression free Survival (PFS)

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

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

  5. Overall Survival (OS)

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

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

  6. Pharmacokinetics of VBC106

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

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

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

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

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

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

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

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

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

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

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

  10. Pharmacokinetics of VBC106: Half-life

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

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

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

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

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

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Study locations

4 sites
  • NEXT Oncology Houston
    Houston, Texas 77054, United States
  • START Mountain Region, LLC.
    West Valley City, Utah 84119, United States
  • NEXT Oncology Virginia
    Fairfax, Virginia 22031, United States
  • Icon Cancer Centre Wesley
    Brisbane, Queensland 4066, Australia
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 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
NCT07686068
Lead sponsor
VelaVigo Bio Inc
Responsible party
Sponsor
First posted
Jul 7, 2026
Start date
Aug 18, 2026 (estimated)
Primary completion
Dec 1, 2028 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Jul 9, 2026

Study contacts

Feng Guo
Contact
feng.guo@VelaVigo.com
17368707951

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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