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Clinical Trial 20298

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT04075396

Phase: Phase I/II
Prinicipal Investigator: Alberto Chiappori

Call 813-745-6100
or 1-800-679-0775 Learn More
Overview

Study Title

A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of YH25448 in Patients with EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)

Summary

The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of YH25448 when given orally to participants with epidermal growth factor receptor single activating mutation positive (EGFRm+) locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC).

Objective

Primary Objective (Part D): To evaluate the safety, tolerability, and pharmacokinetics (PK) of YH25448 when given orally to patients with EGFRm+locally advanced NSCLC. Secondary Objectives: To characterize the PK profiles of potential YH25448 metabolites in plasma, including M7, following a single oral dose and at steady state. To obtain additional assessments of the anti-tumor activity of YH25448 by evaluation of objective response rate (ORR), duration of response (DoR), disease control rate (DCR), tumor shrinkage and progression free survival (PFS) using RECIST 1.1 as assessed by investigator review of radiological information and overall survival (OS).

Treatments

Therapies

Medications

YH25448 ()

Inclusion Criteria

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  • Patient with histologically or cytologically (ie, using pleural effusion, ascites) confirmed NSCLC with previously diagnosed EGFRm+, and who have had progressive disease on prior EGFR-TKI therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to1 patients with no deterioration over the previous 2 weeks and a minimum life expectancy of 3 months.
  • Patients who have at least one measurable extracranial lesion, not previously irradiated and not chosen for biopsy during the study screening period or one measurable lesion that has passed 14 days or more after biopsy, that can be accurately measured at baseline as ≥ 10mm in the longest diameter (except lymph nodes which must have short axis ≥ 15mm) with computerized tomography (CT) or magnetic resonance imaging (MRI), are suitable for accurate repeated measurement.
  • Females should agree to use adequate contraceptive measure, should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of following criteria at screening; Post-menopausal defined as aged more than 50 years and ameorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments; Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation; Women under 50 years old would be considered postmenopausal if they have been ameorrhoeic for at least 12 months following cessation of exogenous hormonal treatment, and have serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels in postmenopausal range for the institution
  • Male participants who have not undergone a vasectomy must agree to use barrier contraception that is, condoms, and refrain from donating sperm until 3 months after last drug is taken
  • During the study, and for 3 months after receiving the last dose of study drug, female participants must agree not to donate eggs (ova, oocytes) and male participants must agree not to donate sperm for the purposes of assisted reproduction.

  • Exclusion Criteria

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  • Symptomatic spinal cord compression (if steroid treatment is not required within at least 2 weeks prior to the start of the study treatment then the participant may be enrolled)
  • Brain metastases with symptomatic and/or requiring emergency treatment (example; Steroid for at least 2 weeks prior to start of study treatment
  • Intracranial hemorrhage with symptomatic and/or requiring treatment
  • CNS complications that require urgent neurosurgical intervention (e.g. resection or shunt placement)
  • An unapproved investigational product from another clinical study within 30 days of the first dose of study treatment
  • Leptomingeal metastasis prior to study treatment
  • Past medical history of interstitial lung disease (ILD), drug-induced IDL, radiation pneumonitirs which required steroid treatment, or any evidence of clinically active ILD.
  • Any cardiovascular disease as follows: (a) History of symptomatic CHF or serious cardiac arrhythmia requiring treatment, (b) history of myocardial infarction or unstable angina within 6 months of the first dose of study treatment (c) LVEF less than 50%.

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