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Irinotecan Hydrochloride Liposome Injection (LY01610) For Advanced Solid Tumors

NCT04088604 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-04-26

No results posted yet for this study

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.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

LY01610 ( Irinotecan hydrochloride liposome injection )

Part1-Dose Escalation and Part1-Dose Extension : subjects take LY01610;

DRUG

LY01610 ( Irinotecan hydrochloride liposome injection ) with 5-Fu（Fluorouracil Injection）

Part2-Dose Escalation and Part2-Dose Extension : subjects take LY01610 with 5-Fu;

DRUG

Irinotecan Hydrochloride Injection（CAMPTO®）

Irinotecan Hydrochloride Injection（CAMPTO®） pharmacokinetics comparative study

Sponsors & Collaborators

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Principal Investigators

  • Huang jing · Chinese Academy of Medical Sciences and Peking Union Medical College

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-15
Primary Completion
2021-12-17
Completion
2021-12-17

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04088604 on ClinicalTrials.gov