NCT05991518

IAH0968 in Combination With GC for the Treatment of HER2-Positive Unresectable Advanced/Metastatic Malignant Tumors

Phase Ib/II Clinical Study of IAH0968 in Combination With Gemcitabine and Cisplatin for the Treatment of HER2-Positive Unresectable Advanced/Metastatic Malignant Tumors and Cholangiocarcinoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study aims to evaluate the efficacy and safety of IAH0968 in combination with gemcitabine and cisplatin for the treatment of HER2-positive unresectable advanced/metastatic malignant tumors and cholangiocarcinoma. The study is divided into two stages: Phase Ib, an open-label, non-randomized, multicenter dose-escalation trial, and Phase II, a randomized, double-blind, parallel-controlled, multicenter trial.

Detailed description

Phase Ib is an open-label, non-randomized, multicenter dose-escalation trial. It utilizes the classic "3+3" design to investigate the safety and tolerability of IAH0968 in combination with gemcitabine and cisplatin for the treatment of HER2-positive unresectable advanced/metastatic malignant tumors and cholangiocarcinoma. Phase II study is a randomized, double-blind, parallel-controlled, multicenter research design. It aims to investigate the efficacy of IAH0968 in combination with gemcitabine and cisplatin for the treatment of HER2-positive unresectable advanced/metastatic malignant tumors and cholangiocarcinoma.

Conditions

• HER2 Gene Mutation

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Injection of IAH0968+Gemcitabine+Cisplatin	Administration of IAH0968 is given once per cycle, with each cycle defined as every 3 weeks.
COMBINATION_PRODUCT	Gemcitabine+Cisplatin	Gemcitabine is administered at a dose of 1000 mg/m2 on the second day (D2) and ninth day (D9) of each cycle. At least 6 hours after the completion of gemcitabine infusion, cisplatin is administered at a dose of 70 mg/m2 on the second day (D2) of each cycle.

Timeline

• Start date: 2023-04-25
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2023-08-14
• Last updated: 2024-02-20

Locations

1 site across 1 country: China