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NOT YET RECRUITING
NCT07772934
PHASE1/PHASE2

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

Sponsor: VelaVigo Bio Inc

View on ClinicalTrials.gov

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

Interventions

DRUG

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