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VBC117First-in-Human Trial of VBC117 in Participants With Advanced Malignant Solid Tumors
Sponsor: VelaVigo Bio Inc
Summary
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.
Official 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
260
Start Date
2026-08-24
Completion Date
2029-05-28
Last Updated
2026-09-22
Healthy Volunteers
No
Conditions
Interventions
VBC117
VBC117 is a epidermal growth factor receptor (EGFR)x Cadherin-17 (CDH17) bispecific antibody-drug conjugate (ADC).
Locations (12)
Macquarie University
Randwick, New South Wales, Australia
Scientia Clinical Research
Randwick, New South Wales, Australia
Cancer Care Wollongong
Wollongong, New South Wales, Australia
Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
The Second Affiliated Hospital of Zhejiang University School of Medicine
Zhejiang, Hangzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Liaoning Cancer Hospital & Institute
Shengyang, Liaoning, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Shanghai GoBroad Cancer Hospital
Shanghai, Shanghai Municipality, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China