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

NCT05991518 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2024-02-20

No results posted yet for this study

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.

Conditions

  • HER2 Gene Mutation

Interventions

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.

Sponsors & Collaborators

  • SUNHO（China）BioPharmaceutical CO., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhou Jian, M.D. · Fudan University

  • Liu Tianshu, M.D. · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-25
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05991518 on ClinicalTrials.gov