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Clinical Trial Summary

This is a multicenter, open-label, dose-escalation, dose-expansion, and cohort-expansion Phase I/II clinical study to evaluate safety, tolerability, pharmacokinetics, antitumor efficacy and to determine the maximum tolerated dose (MTD) and recommended Phase 2 doses (RP2D) of cisplatin micelle injection in patients with advanced malignant solid tumors. This study is divided into two stages, the first stage (stage I) is the dose escalation and dose expansion study of cisplatin micelle injection, to determine the maximum tolerated dose (MTD), and to initially explore the recommended dose of phase II clinical practice (RP2D). The second stage (stage II) is the cisplatin micelle injection cohort expansion study to evaluate the efficacy and safety of cisplatin micelle injection (HA132) in patients with advanced solid tumors.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05478785
Study type Interventional
Source CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Contact Xianying Piao, doctor
Phone +86-17813168890
Email piaoxianying@mail.ecspc.com
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date August 2022
Completion date August 2025

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