NCT04934514

Clinical Study of IAH0968 in Patients With HER2-positive Advanced Solid Tumors

A Phase I/IIa Study of IAH0968 in Patients With HER2-positive Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 97 (estimated)
• Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I/IIa study to evaluate the safety, tolerability and preliminary efficacy of IAH0968 in patients with HER2-positive advanced solid tumors who have failed standard treatment.

Detailed description

The purpose of the Phase Ia/Ib study is to evaluate the tolerability, safety, PK, immunogenicity and preliminary anti-tumor activity of IAH0968 in Chinese subjects. Phase Ia is a dose escalation, and it is planned to recruit about 10-19 subjects with HER2-positive advanced malignancies who have failed standard treatment. Phase Ib is a dose expansion, and it is planned to recruit approximately 18 subjects with HER2-positive advanced malignancies who have failed standard treatment. Phase IIa mainly investigates the effectiveness and safety of IAH0968 in HER2-positive subjects with advanced biliary system tumors.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	IAH0968	IAH0968 is an investigational product.
DRUG	Gemcitabine	Gemcitabine 1000 mg/m\^2 intravenous infusion
DRUG	Cisplatin	Cisplatin 75 mg/m\^2 intravenous infusion

Timeline

• Start date: 2021-07-06
• Primary completion: 2024-12-31
• Completion: 2025-03-31
• First posted: 2021-06-22
• Last updated: 2024-02-20

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study