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A Study to Investigate the Safety of SYHA1815 in Subjects With Unresectable Locally Advanced or Metastatic Solid Tumors

NCT05105464 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2021-11-03

No results posted yet for this study

Summary

This is a multi-center, open-label, dose escalation and expansion, phase I study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) characteristics, preliminary efficacy of SYHA1815 in subjects with unresectable locally advanced or metastatic solid tumors. Once the expected effective dose is identified, the dose expansion study will be started to further evaluate the safety, clinical activity and PK profile of SYHA1815 in subjects with unresectable locally advanced or metastatic solid tumors.

Conditions

  • Locally Advanced Unresectable Carcinoma

Interventions

DRUG

SYHA1815

Subjects will receive SYHA1815 orally.

Sponsors & Collaborators

  • Jilin Provincial Tumor Hospital

    collaborator OTHER

  • Shanghai Runshi Pharmaceutical Technology Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Huang Yanli, PD · CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-06-25
Primary Completion
2023-09-30
Completion
2023-09-30

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 NCT05105464 on ClinicalTrials.gov