NCT05423977

Study of ZV0203 in Patients With HER2-Positive Advanced Solid Tumors

An Open-label, Multicenter, Phase I Dose-escalation Study to Assess the Safety, Pharmacokinetic (PK), Immunogenicity and Preliminary Anti-tumor Activity of ZV0203 in Patients With HER2-Positive Advanced Solid Tumors

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Hangzhou Adcoris Biopharmacy Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An open-label, multicenter, phase I dose-escalation study to assess the safety, Pharmacokinetic (PK), immunogenicity and preliminary anti-tumor activity of ZV0203 in patients with HER2-Positive advanced solid tumors

Conditions

• HER2-positive Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	ZV0203	Participants will be allocated to one of the following dose groups: 0.3, 0.6, 1.2, 1.8, 2.7 and 3.6 mg/kg, and receive a treatment of ZV0203-ADC followed by 21 days of dose limited toxicity (DLT) observation period.

Timeline

• Start date: 2021-12-17
• Primary completion: 2023-05-05
• Completion: 2026-07-07
• First posted: 2022-06-21
• Last updated: 2025-09-30

Locations

1 site across 1 country: China