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Phase I Clinical Study of YL-15293 in Patients With Advanced Solid Tumor With KRAS Mutation

NCT05173805 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-07-18

No results posted yet for this study

Summary

This is a phase 1 / 2 open label multicenter study to evaluate the maximum tolerance, safety, tolerance and PK of oral YL-15293 in patients with advanced solid tumors with KRAS mutation, so as to confirm the recommended phase 2 dose of YL-15293 and obtain the preliminary efficacy information of patients with advanced solid tumors with KRAS mutation.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

YL-15293

After enrollment, patients will receive oral YL-15293 twice a day until disease progression, unacceptable adverse events, concurrent diseases prevent further study treatment, the investigator decides to withdraw the patient, the patient withdraws consent, the patient is pregnant, or for administrative reasons. After treatment, the patients will continue to be followed up for 30 days. Patients who permanently stop the study treatment for reasons other than disease progression will be followed up for disease evaluation after treatment until the start of new anti-cancer treatment, withdrawal of consent, loss of follow-up, death or until the sponsor stops the study, whichever comes first.

Sponsors & Collaborators

  • Shanghai YingLi Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Li Zhang, PH D · Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-30
Primary Completion
2024-04-30
Completion
2024-12-30

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 NCT05173805 on ClinicalTrials.gov