A Multicenter Phase I/II Clinical Study to Evaluate the Safety and Primary Efficacy of LY01616 (Irinotecan Hydrochloride and Floxuridine Liposome Injection) in Patients With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- LY010616
- Conditions
- Advanced Solid Tumors
- Sponsor
- Luye Pharma Group Ltd.
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Incidence and severity of adverse events (AEs) .
- Status
- Enrolling By Invitation
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a multicenter, open, dose escalation, single and multiple administration phase Ⅰ/Ⅱ clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), and primary clinical efficacy of LY01616 in patients with advanced solid tumors
Investigators
Eligibility Criteria
Inclusion Criteria
- •A signed informed consent form (ICF) from the patient or their legally authorized representative. It has fully understood and voluntarily signed the written informed consent for this study, and can comply with the requirements and restrictions listed in the informed consent;
- •males or females, ages ≥18 to ≤70 years；
- •Patients with advanced solid tumors confirmed by histopathology and/or cytology, who are ineffective or unable to tolerate standard treatment, or who have no standard effective treatment plan (preferred target tumors such as colorectal cancer, gastric cancer, esophageal cancer, pancreatic cancer, small cell lung cancer, soft tissue sarcoma, cervical cancer, etc.);
- •At least one measurable lesion (according to RECIST 1.1 criteria);
- •5.ECOG \< 2;
- •Organ function meets the following criteria during screening: i.Blood routine examination: neutrophil count (ANC) ≥1.5×109/L, platelet (PLT) ≥100×109/L, hemoglobin (Hb) ≥90g/L; ii.Liver function: Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5×ULN; If liver metastasis is present, AST and ALT≤5×ULN; iii.Renal function: serum creatinine ≤1.5×ULN or creatinine clearance ≥50mL/min (Cockcroft-Gault formula).
Exclusion Criteria
- •Having a malignant tumor of the brain or other malignant hematological disease;
- •Complicated with symptomatic brain metastasis, meningeal metastasis, spinal cord tumor invasion and spinal cord compression;
- •Other malignancies (except cured cervical cancer of stage IB or lower, and non-invasive basal cell or squamous cell skin cancer) within 5 years prior to screening;
- •Uncontrollable large pleural effusion, ascites and pericardial effusion;
- •Persistent or active infection requiring intravenous treatment; If there is bleeding as determined by the investigator, it is not appropriate to enroll; Fever (axillary temperature ≥38℃);
- •History of acute coronary syndrome, coronary revascularization, New York Heart Association (NYHA) grade ≥II cardiac dysfunction, severe unstable ventricular arrhythmias within 6 months; Or an arrhythmia requiring treatment at the time of screening;
- •Anti-hepatitis C virus antibody (HCV-AB) positive, anti-human immunodeficiency virus antibody (anti-HIV) positive or syphilis antibody positive, active hepatitis B \[hepatitis B surface antigen (HBsAg) positive test, And peripheral blood HBV DNA titer detection ≥ 1 x 103 copies /mL or 200 IU/ mL; if HBsAg positive, and peripheral blood HBV DNA titer detection \< 1 x 103 copies /mL or 200 IU/ mL, If the investigator believes that the subject's chronic hepatitis B is stable and does not increase the subject's risk, the subject will be eligible for admission\];
- •Electrolyte disturbances with clinical significance judged by the researcher still existed before study administration;
- •Severe gastrointestinal disorders (such as gastrointestinal bleeding, infection, chronic enteritis, obstruction, or CTCAE grade 1 or above diarrhea) at the time of screening;lts for drug.
- •10.A past or ongoing history of neuropathy or mental disorder (including epilepsy or dementia);
Arms & Interventions
LY010616(30 mg/m2)
30 mg/m2 measured by Irinotecan hydrochloride, IV infusion was 90min (±5min), with an interval of 3 weeks between the first administration and the second administration, and once every 2 weeks thereafter)
Intervention: LY010616
LY010616(60 mg/m2)
60 mg/m2 measured by Irinotecan hydrochloride, IV infusion was 90min (±5min), with an interval of 3 weeks between the first administration and the second administration, and once every 2 weeks thereafter)
Intervention: LY010616
LY010616(90 mg/m2)
90 mg/m2 measured by Irinotecan hydrochloride, IV infusion was 90min (±5min), with an interval of 3 weeks between the first administration and the second administration, and once every 2 weeks thereafter)
Intervention: LY010616
LY010616(120 mg/m2)
120 mg/m2 measured by Irinotecan hydrochloride, IV infusion was 90min (±5min), with an interval of 3 weeks between the first administration and the second administration, and once every 2 weeks thereafter)
Intervention: LY010616
LY010616(150 mg/m2)
150 mg/m2 measured by Irinotecan hydrochloride, IV infusion was 90min (±5min), with an interval of 3 weeks between the first administration and the second administration, and once every 2 weeks thereafter)
Intervention: LY010616
LY010616(180 mg/m2)
180 mg/m2 measured by Irinotecan hydrochloride, IV infusion was 90min (±5min), with an interval of 3 weeks between the first administration and the second administration, and once every 2 weeks thereafter)
Intervention: LY010616
Outcomes
Primary Outcomes
Incidence and severity of adverse events (AEs) .
Time Frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment, up to 2 years.
Secondary Outcomes
- Objective response rate (ORR)(up to 2 years)
- Area under the curve (AUC) of LY01616(up to cycle 6nd (cycle 1st is 21 days, the other cycles are 14 days))
- Time of maximum concentration (Tmax) of LY01616(up to cycle 6nd (cycle 1st is 21 days, the other cycles are 14 days))
- Maximum Concentration (Cmax) of LY01616(up to cycle 6nd (cycle 1st is 21 days, the other cycles are 14 days))
- Progression-free survival (PFS)(up to 2 years)
- Disease control rate (DCR)(up to 2 years)
- Overall survival (OS);(up to 2 years)
- Duration of remission (DoR)(up to 2 years)