NCT06806982

A Study of VRN101099 in Patients With HER2-Positive Solid Tumors

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of VRN101099 in Patients With HER2-Positive Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Voronoi, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This FIH open-label study aims to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor effect of VRN101099 in patients with HER2-positive solid tumors for whom no standard therapies are available.

Detailed description

This is an open-label study where eligible patients will receive VRN101099 capsules orally, once daily (QD) at the specified dose level, in repeated 21-day treatment cycles until disease progression (PD), death, loss to follow-up, start of another anticancer treatment, intolerable toxicity, withdrawal of consent, or study completion or closure (whichever occurs first). Dose limiting toxicities (DLTs) will be monitored during the first cycle of treatment (i.e., 21 days of IP administration, Cycle 1). The proposed VRN101099 dose levels are: 80 mg QD, 160 mg QD, 240 mg QD, 320 mg QD, 400 mg QD, and 480 mg QD. Safety Monitoring committee will be setup for review DLTs and overall safety data. Border medical oncology in Australia will be using Omico for CaSP NGS screening participants to the study.

Conditions

• HER2-positive Solid Tumors

Interventions

Type	Name	Description
DRUG	VRN101099	Oral capsules

Timeline

• Start date: 2025-02-17
• Primary completion: 2026-05-01
• Completion: 2027-07-31
• First posted: 2025-02-04
• Last updated: 2025-08-28

Locations

1 site across 1 country: Australia