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A Study Evaluating SYHX2005 in the Treatment of Patients With Advanced Solid Tumors

NCT05609019 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2022-11-08

No results posted yet for this study

Summary

This is a first-in-human study with the SYHX2005 tablet primarily designed to evaluate the safety and tolerability of SYHX2005 at increasing doses in patients with advanced solid tumors and for whom no standard of care exists. The study will be conducted in two parts: Stage1 dose-escalation and Stage2 dose-expansion. In Stage1, patient enrolment will be proceeded according to a "Accelerated Titration + BOIN" design in order to identify the maximum-tolerated dose (MTD) or recommended dose. In Stage2, preliminary efficacy response will be assessed in patients with advanced solid tumors in use of the recommended dose.

Conditions

Interventions

DRUG

SYHX2005

Tablets. Take orally.

Sponsors & Collaborators

  • CSPC Ouyi Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2024-12-31
Completion
2025-12-31

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Entities

Diseases

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 NCT05609019 on ClinicalTrials.gov