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The primary objective of this study is to evaluate the safety and tolerability of TY-9591, with dose-escalation stage and dose-expansion stage.
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Inclusion criteria
18-75years old, male or female.
Histological or cytological confirmation diagnosis of NSCLC
At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
Life expectancy of at least 3 months.
Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
Documentation of disease progression while on previous continuous treatment with first-line EGFR TKI; patients must have confirmation of tumor EGFR activating mutations (exon 19 del, or exon 21 ) and T790M mutation status
Adequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
a.Neutrophils (absolute value) ≥ 1.5×10^9/L; b.Hemoglobin ≥ 90 g/L; c.Platelet ≥ 80×10^9/L; d.Serum total bilirubin ≤ 1.5× ULN(for Patients with Gilbert Syndrome, total bilirubin ≤ 3×ULN and bilirubin ≤ 1.5×ULN should be permitted) f. Aspartate aminotransferase(AST)、alanine aminotransferase(ALT) ≤ 2.5×ULN; for patients with hepatic metastases, AST、ALT ≤ 5×ULN; g. International standardized ratio (INR) < 1.5, and activated partial prothrombin time (APTT) < 1.5×ULN;
Female subjects have a negative urine or serum pregnancy.
Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.
Exclusion criteria
Treatment with any of the following:
Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy.
Spinal cord compression or brain metastases unless asymptomatic.
Dysphagia, or active digestive system diseases or previous significant bowel resection or medical conditions potentially affect TY-9591 absorption.
Cardiac function and disease are consistent with the following:
Active human immunodeficiency virus (HIV), syphilis, hepatitis c virus (HCV) or hepatitis b virus (HBV) infection, with the exception of asymptomatic chronic hepatitis b or hepatitis c carriers.
7 .Previous history of interstitial lung disease(ILD)、drug-induced ILD or radiation pneumonitis require steroid treatment, or any evidence of clinically active ILD diseases.
Primary purpose
Allocation
Interventional model
Masking
105 participants in 1 patient group
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Central trial contact
Baohui Han, MD
Data sourced from clinicaltrials.gov
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