NCT07083323

A Phase I/II Study of HY05350 in Mesothelin(MSLN)-Positive Advanced Solid Tumors

A Multicenter, Open-label Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Clinical Efficacy of HY05350 for Injection in Patients With MSLN-positive Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 262 (estimated)
• Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a multicenter, open-label Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary clinical efficacy of HY05350 for injection in patients with MSLN-positive advanced solid tumors.

Detailed description

This study is a multicenter, open-label phase I/II clinical trial divided into two parts: dose escalation part (Part 1) and dose expansion part (Part 2). The main objectives of the first part are to evaluate the safety and tolerability of HY05350 for injection as monotherapy in patients with mesothelin-positive advanced solid tumors, and to explore the Maximum Tolerated Dose (MTD) and determine the Recommended Phase 2 Dose (RP2D) or the recommended dose for subsequent clinical studies. The main objective of the second part is to evaluate the anti-tumor efficacy of HY05350 for injection. The study includes patients with cytologically or pathologically confirmed advanced solid tumors who have failed standard treatment.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	HY05350 for injection	HY05350 should be administered intravenously at planned dosage, once a week, once every two weeks, or once every three weeks, until disease progression or intolerable toxicity occurs.
DRUG	HY05350 for injection	HY05350 should be administered intravenously at recommended dose, once a week, once every two weeks, or once every three weeks, until disease progression or intolerable toxicity occurs.

Timeline

• Start date: 2025-07-22
• Primary completion: 2028-03-31
• Completion: 2028-03-31
• First posted: 2025-07-24
• Last updated: 2025-11-25

Locations

1 site across 1 country: China