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A Phase 1/2, Study of YL-15293 in Subjects With Advanced Solid Tumors With a KRAS G12C Mutation

NCT05119933 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2021-11-15

No results posted yet for this study

Summary

This is a Phase 1/2, open-label, multicenter study designed to evaluate the maximum tolerated, safety, tolerability and PK of oral YY-15293 in patients with advanced solid tumors with a KRAS G12C mutation, to confirm the recommended phase 2 dose of YY-15293, and to obtain preliminary efficacy information in patients with advanced non-small cell lung cancer (NSCLC) with a KRAS G12C mutation.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

YL-15293

After a screening period of approximately 28 days, eligible patients will receive oral YL-15293 once daily until documented disease progression, unacceptable AEs, intercurrent illness prevents further administrations of study treatment, investigator's decision to withdraw the patient, the patient withdraws consent, pregnancy of the patient, or for administrative reasons (see Section 7.1). 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 withdraws consent, is lost to follow-up, death, or until the Sponsor stops the study, whichever comes first.

Sponsors & Collaborators

  • Yingli Pharma US, Inc

    collaborator UNKNOWN

  • Shanghai YingLi Pharmaceutical Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-09
Primary Completion
2023-06-01
Completion
2023-12-01
FDA Drug
Yes

Countries

  • United States

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 NCT05119933 on ClinicalTrials.gov