NCT07222969

A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors

An Open-label, Dose-escalation and Dose-expansion Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) Characteristics, and Preliminary Efficacy of VIB305 in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Vibrant Sciences Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is an open-label, single-arm, non-randomized, dose-escalation and dose-expansion study targeting subjects with unresectable, advanced, malignant solid tumors who have failed or are unsuitable for standard treatments or refused the existing treatments. This study is divided into a dose-escalation phase (Phase I) and a dose-expansion phase (Phase II). Phase I (dose escalation) is designed to preliminarily evaluate the safety and tolerability of VIB305 in advanced solid tumors, to determine the nature and incidence of dose-limiting toxicities (DLTs), and thereby to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Based on the findings from the Phase I portion for evaluation in the Phase II portion. Phase II (dose expansion) will enroll additional cohorts to further assess the safety and tolerability, PK profile, preliminary antitumor activity and immunogenicity of VIB305 in specific tumor types (selected based on all available data).

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	VIB305 for Injection	Intravenous infusion: once every week, each treatment cycle is 3 weeks.

Timeline

• Start date: 2026-01-12
• Primary completion: 2027-04-30
• Completion: 2027-06-30
• First posted: 2025-10-30
• Last updated: 2026-03-23

Locations

2 sites across 2 countries: Australia, China

Regulatory

• FDA-regulated drug study