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

A Phase 1, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10342 in Patients With Advanced Solid Tumor

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04060511

Enrollment

Registered

2019-08-19

Start date

2019-06-19

Completion date

2021-09-15

Last updated

2023-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumor

Keywords

CDK4/6 inhibitor, advanced solid tumor

Brief 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.

Detailed description

This is a phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-10342 in patients with advanced solid tumor by using a 3+3 dose escalation.

Interventions

DRUGHS-10342

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects must meet all of the following inclusion criteria to be eligible for participation in this study: 1. Pathologically confirmed solid tumor and failed from all standard treatment. 2. At least one extracranial measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1. 3. Eastern Cooperative Oncology Group (ECOG) performance status: 0-1. 4. Life expectancy ≥ 3 months. 5. Adequate function of major organs meets the following requirements: * Neutrophils ≥ 1.5×10\^9/L * Platelets ≥ 90×10\^9/L * Hemoglobin ≥ 90g/L * Total bilirubin≤ 1.5 × the upper limit of normal (ULN) * ALT and AST ≤ 2.5 × ULN * Cr ≤ 1.5 × ULN * Left ventricular ejection fraction (LVEF) ≥ 40% 6. Good compliance of patient by physician's judgement. 7. . Signed and dated informed consent.

Exclusion criteria

* Subjects who meet any of the following

Design outcomes

Primary

Measure	Time frame	Description
Dose-Limiting Toxicity and Maximum Tolerated Dose of HS-10342.	5 weeks	The maximum-tolerated dose (MTD) will be defined as the maximum dose level at which no more than one out of three subjects experience a dose-limiting toxicity (DLT) within the 5 week after the first dose.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026