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NCT Number: NCT07772934

VBC117First-in-Human Trial of VBC117 in Participants With Advanced Malignant Solid Tumors

Detailed Description: This is a multicenter, open-label, multiple-dose, first in human(FIH) Phase 1/2a trial. The Phase 1 portion uses the Bayesian optimal interval (BOIN) design to escalate doses and determine the maximum tolerated dose(MTD) and/or recommended phase 2 dose(RP2D) with potential backfill cohorts. The Phase 2a portion consists of dose optimization followed by cohort expansion to confirm safety and tolerability and further evaluate the efficacy of the selected RP2D in selected solid tumor malignancies treated with VBC117.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Macquarie University, Randwick, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 EGFR x CDH17 bispecific ADC.
  • Prior treatment with any ADC carrying a topoisomerase I inhibitor (TOP1i) payload.
  • Has a medical history of interstitial lung diseases or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.

Treatment and study plan

VBC117

Drug

VBC117 is a epidermal growth factor receptor (EGFR)x Cadherin-17 (CDH17) bispecific antibody-drug conjugate (ADC).

Primary outcomes

  1. Incidence of AEs

    Time frame: From time of Informed Consent to 30 days post last dose of VBC117

    Number of patients with Adverse Events（AEs）by system organ class and preferred term

  2. Incidence of DLTs

    Time frame: From time of first dose of VBC117 to end of DLT period (approximately 21 days)

    Incidence of dose-limiting toxicities (DLT) as defined in the protocol

  3. Incidence of SAEs

    Time frame: From time of Informed Consent to 30 days post last dose of VBC117

    Number of patients with Serious Adverse Events(SAEs)by system organ class and preferred term

  4. Incidence of TEAE leading to dose modification or discontinuation

    Time frame: From time of Informed Consent to 30 days post last dose of VBC117

    Number of patients with treatment-emergent adverse event (TEAE) leading to dose modification or discontinuation by system organ class and preferred term

  5. objective response rate (ORR)

    Time frame: From first dose of VBC117 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

Sponsors and collaborators

Lead sponsor

VelaVigo Bio Inc

Industry

Registry information

Official study title

Phase 1/2a Open-label Clinical Trial Evaluating VBC117, an EGFR and CDH17-directed Bi-specific Antibody Drug Conjugate, in Participants With Advanced Malignant Solid Tumors

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 19, 2026
Registry last updated
Aug 19, 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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