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A Study of YL-17231 in Patients With Advanced Solid Tumors

NCT06078800 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-10-12

No results posted yet for this study

Summary

This is a phase 1 open label multicenter study to evaluate the maximum tolerance, safety, tolerance and PK of oral YL-17231 in patients with advanced solid tumors with KRAS mutation, so as to confirm the recommended phase 2 dose of YL-17231 and obtain the preliminary efficacy information of patients with advanced solid tumors with KRAS mutation.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

YL-17231

After a screening period of approximately 14 days, eligible patients will receive oral YL-17231 once or twice daily until documented disease progression, unacceptable AEs, intercurrent illness preventing further administrations of study treatment, investigator's decision to withdrawal, the patient's consent of withdrawal, pregnancy, or for administrative reasons. Following the end of treatment, patients will continue to be followed for safety for 30 days. Patients who permanently discontinue study treatment for reasons other than disease progression will have post-treatment follow-up for disease assessment until start of new anticancer treatment, patient's consent of withdrawal, lost to follow-up, death, or until the Sponsor stops the study, whichever comes first.

Sponsors & Collaborators

  • Shanghai YingLi Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Xu Ruihua, PhD · Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2023-09-28
Primary Completion
2025-03-31
Completion
2025-12-31

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 NCT06078800 on ClinicalTrials.gov