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A Study of HS-10342 in Patients With Advanced Solid Tumor

NCT04060511 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2023-03-09

No results posted yet for this study

Summary

HS-10342 is a small molecular, oral potent, selective CDK4/6 inhibitor. The purpose of this study is to investigate the safety/tolerability and the pharmacokinetic profile of HS-10342 in Chinese advanced solid tumor patients. Preliminary efficacy will be also investigated in this study.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

HS-10342

HS-10342 either 25mg, 50mg, 100mg, 150mg, 200mg given orally, QD or 50mg, 100mg, 150mg, 200mg, 250mg, 275mg given orally, BID

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Binhe Xu, MD · Cancer Hosptial, Chinese Academy of Medical Sciences

  • Herui Yao, MD · Second Affiliated Hospital, Sun Yat-Sen University

  • Qiang liu, MD · Second Affiliated Hospital, Sun Yat-Sen University

  • Yongmei Yin, MD · Jiangsu Provincial People's Hospital, Jiangsu Province, Nanjing 210029, China

  • Min Yan, MD · Henan Cancer Hospital

  • Yanxia Shi, MD · Sun Yat-sen University Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-19
Primary Completion
2020-12-04
Completion
2021-09-15

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 NCT04060511 on ClinicalTrials.gov