NCT07069062

A Phase I/Ⅱ Human Study of HY0001a for Injection in Adult Participants With Advanced Solid Tumors

A Multicenter, Open-label Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Clinical Efficacy of HY0001a for Injection in Patients With Advanced Malignant Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 261 (estimated)
• Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, phase I/Ⅱ study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic(PD) characteristics of HY0001a for injection in participants with advanced solid tumors.

Detailed description

This is a first-in-human (FIH), Phase I/II, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HY0001a for injection in patients with advanced/metastatic solid tumors. HY0001a for injection is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify the maximum tolerated dose (MTD) and dose-limiting toxicities（DLT）. In addition, the maximum-tolerated dose and recommended Phase II dose for HY0001a for injection will be determined.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Test product HY0001a for injection	HY0010a for injection should be administered at the recommended dosage

Timeline

• Start date: 2025-07-21
• Primary completion: 2027-06-01
• Completion: 2027-09-01
• First posted: 2025-07-16
• Last updated: 2026-03-09

Locations

1 site across 1 country: China