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ENROLLING BY INVITATION
NCT05865925
PHASE1/PHASE2

Safety, Tolerability, Pharmacokinetics (PK), and Primary Clinical Efficacy of LY01616 in Patients With Advanced Solid Tumors

Sponsor: Luye Pharma Group Ltd.

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2021-04-22

Completion Date

2024-10-30

Last Updated

2024-04-25

Healthy Volunteers

No

Interventions

DRUG

LY010616

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

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China