Irinotecan Hydrochloride Liposome Injection (LY01610) For Advanced Solid Tumors

Sponsor
Luye Pharma Group Ltd.
Study ID
NCT04088604
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Feb 15, 2019
Status verified
Apr 2023
Primary completion
Dec 17, 2021
Completion
Dec 17, 2021

Study Design

Enrollment
38 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LY01610-Dose Escalation
    The starting dose was 30 mg/m2 IV and the subsequent dose was increased according to the protocol of 60 mg/m2, 90 mg/m2, 120 mg/m2, 150 mg/m2, 180mg/m2. The interval between the first dose and the second dose was 3 weeks, followed by 2 weeks.
  • Experimental: LY01610-Dose Extension
    According to the subjects' tolerance, appropriate dose will be selected and the safety, PK characteristics and initial efficacy of LY01610 were further evaluated in 6 - 8 patients. The interval between the first dose and the second dose was 3 weeks, followed by 2 weeks.
  • Experimental: LY01610 with 5-Fu -Dose Escalation
    Dose Escalation: Based on the results of the first stage, three doses of low, medium and high doses were selected in combination with a fixed dose of 5-Fu to determine the DLT, MTD, PK characteristics and the preliminary efficacy. 5-Fu, 400mg/m2 will be administered intravenously on days 1, followed by 600 mg/m2 given as a 22-hour continuous infusion on day 1 and 2, every 2 weeks.
  • Experimental: LY01610 with 5-Fu -Dose Extension
    Similarly, according to the subjects' tolerance, appropriate dose will be selected and the safety, PK characteristics and initial efficacy of LY01610 combined with a fixed dose of 5-Fu were further evaluated in additional 6 - 8 patients. In dose escalation and dose extension stages, both LY01610 and fixed dose 5-Fu will be given once every 2 weeks.
  • Active Comparator: Hydrochloride Injection- pharmacokinetics comparative study
    After receiving the MTD of LY01610, another 8 subjects were enrolled and given Irinotecan Hydrochloride Injection（captol ®） (180mg/m2) once every 2 weeks. Upon completion of the pharmacokinetics study, the sponsor will continue to provide the study drug treatment free of charge, and the researcher will conduct treatment and examination according to the subject's situation, without collecting any safety and efficacy data of the subject.

Primary Outcome Measure

Dose limiting toxicity (DLT) [ Time Frame: 21 days for the LY01610 monotherapy (first treatment cycle of every subjects) ]

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