Irinotecan Hydrochloride Liposome Injection (LY01610) For Advanced Solid Tumors

• Status: Unknown status
• Trial end date: 2021-02-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase I, open-label, non-randomized, dose-escalation study to evaluate the safety and tolerability, the maximum tolerated dose (MTD) and the dose limited toxicity(DLT) of LY01610 monotherapy and combine with 5-Fu in patients with advanced solid tumors. Additionally, the pharmacokinetics and preliminary efficacy of LY01610 monotherapy and combine with 5-Fu will be investigated in this study.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Luye Pharma Group Ltd.
• Treatments: Fluorouracil; Irinotecan

Criteria

Inclusion Criteria:

• Male or female patients aged 18 to 70 years (18 years and 70 years are inclusive).

• Histologically or cytologically confirmed solid tumor for which failed or could not •tolerate standard treatment, or standard effective treatment does not exist.

• The patient should have at least one measurable lesion as the target lesion (according to RECIST 1.1 criteria).

• The predictable survival duration ≥ 3 months.

• The Eastern Cooperative Oncology Group (ECOG) performance status score < 2 point.

• Laboratory results during screening:

• Hematology: Absolute neutrophil count ≥ 1.5× 109/L, platelet count≥ 100× 109/L and hemoglobin≥ 90 g/L;

• Liver function: Total bilirubin（TBIL）≤ 1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN for the subjects without liver metastasis; ALT and AST≤ 5×ULN for the subjects with liver metastasis;

• Kidney function: Serum creatinine ≤ 1.5 ×ULN or creatinine clearance rate ≥ 50 mL/min(Cockcroft-Gault formula);

• The subject has voluntarily signed the written informed consent form (ICF) and can comply with the study protocol;

• The female subjects of childbearing age and male subjects with fertility potential female partner agree to take reliable contraceptive measures (such as abstinence, sterilizing operation, contraceptives, injection of the contraceptive drug •medroxyprogesterone acetate or subdermal implant of contraceptives) during the study period and within 6 months after infusion of the study drugs.

Exclusion Criteria:

• Patients with brain malignant tumor, lymphoma or other malignant blood diseases;

• The subjects with symptomatic brain metastasis;

• Other malignant tumors within 5 years prior to screening (except for stage Ib or lower cervical cancer, non-invasive basal cells or squamous cell skin cancer that have been cured);

• Patients with uncontrollable ascites, pleural effusion;

• Ongoing or active systemic infection need intravenous antibiotic treatment;

• Medical history of the following diseases within 6 months before screening: myocardial infarction, unstable angina, history of coronary revascularization, congestive heart failure (New York Heart Association classification ≥ grade II), severe unstable ventricular arrhythmia, serious arrhythmia which needs drug treatment;

• The patient with hepatitis B surface antigen (HBsAg) positive and the peripheral blood HBV DNA titer ≥1× 103 copies/mL or 200 IU/ml The subject is eligible to be enrolled if HBsAg is positive and peripheral blood hepatitis B virus (HBV) DNA titer <1×103 copies/ml or 200 IU/ml and the investigator considers that the subject is at the stable stage of chronic hepatitis and the risk will not be increased for the subjects;the patient with hepatitis C virus (HCV) antibody and human immunodeficiency virus (HIV) antibody positive;

• Patients still with clinically significant electrolyte disorders that were diagnosed by the investigator before drug administration;