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A Study of KC1036 in Patients with Advanced Solid Tumors
Sponsor: Beijing Konruns Pharmaceutical Co., Ltd.
Summary
The purpose of this study is to evaluate the safety,tolerability, pharmacokinetics, and preliminary efficacy of KC1036 in participants with advanced recurrent or metastatic solid tumors. The trial will be divided into three parts: dose-escalation phase, dose-expansion phase, RP2D-extension phase.
Official title: A Phase I, Open-label, Dose Escalation Study Evaluating the Safety, Pharmacokinetics and Preliminary Efficacy of KC1036 in the Patients with Advanced Recurrent or Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
207
Start Date
2020-09-04
Completion Date
2025-12-31
Last Updated
2024-10-17
Healthy Volunteers
No
Conditions
Interventions
KC1036
Part 1: Dose-escalation phase , KC1036 10mg\~80mg, consists of 5 Cohorts. Part 2: Dose-expansion phase, consists of 3\~4 Cohorts based on part 1. Part 3:RP2D-extension phase, Recommended dose of KC1036 based on part 1and part 2.
Locations (3)
ChongQing University Cancer Hospital
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
West China Hospital
Chengdu, Sichuan, China