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A Study of HS269 in Patients With Advanced Solid Tumors

NCT05058352 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-09-27

No results posted yet for this study

Summary

This is a Phase I, open-label, first in human study of HS269 tablet, a small molecule highly-selective RET Inhibitor. The dose-escalation study will assess the safety, tolerability, and pharmacokinetics of HS269 and determine the dose and schedule to be used in Phase II. Seventeen to thirty-six patients with advanced solid tumor may be enrolled in this study.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

HS269

Oral tablets, once daily. Dose escalation from 50 mg QD, through 100 mg, 200mg, 300 mg, 400 mg, to 500mg.

Sponsors & Collaborators

  • Zhejiang Hisun Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Qiming Wang · Henan Provincial People's Hospital

  • Qi Dang · Shandong Cancer Hospital and Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2022-10-31
Completion
2023-04-30

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 NCT05058352 on ClinicalTrials.gov