A Study of Irinotecan Hydrochloride Liposome in Combination With 5-FU/LV in Advanced Solid Tumors

NCT05086848 | Completed Phase 1

• 1 other identifier: YLTKL-Ib
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a dose-escalation and expansion, open label, single centre, phase Ib study. In this study, the tolerability, safety, pharmacokinetics and efficacy of irinotecan hydrochloride liposome injection in combination with 5-FU/LV were studied in patients with advanced solid tumors. Meanwhile, to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of irinotecan hydrochloride liposome.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Adverse Event (AE)

  Assessed by CTCAE v4.03

  Assessed from study inclusion to 30 days after last dose

• Dose Limiting Toxicities (DLT)

  Dose Limiting Toxicities for patients in combination treatment

  DLTs will be evaluated during 28-day period following the first dose of study treatment

• Maximal tolerated dose (MTD)

  Maximum tolerated dose for patients in combination treatment

  after the last patient in each cohort up to 12 months

Secondary Outcomes (9)

• Objective Response Rate

  maximum time on study 12 months

• Progression Free Survival

  The maximum time in follow up was 12 months

• Time to reach maximum plasma concentration (Tmax)

  up to 168 hours after the first dose

• Maximum observed plasma concentration (Cmax)

  up to 168 hours after the first dose

• Area under the plasma concentration versus time curve from time zero to time of last observed concentration (AUC0-t)

  up to 168 hours after the first dose

Study Arms (1)

Treatment group:

EXPERIMENTAL

Irinotecan liposome plus 5-fluorouracil, Leucovorin

Drug: Irinotecan liposome、5-fluorouracil、Leucovorin

Interventions

Irinotecan liposome、5-fluorouracil、Leucovorin DRUG

Irinotecan liposome、5-fluorouracil、Leucovorin

Treatment group:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed solid tumors documented as advanced or metastatic disease;
• Subjects must be considered relapsed or refractory to standard therapies, have been intolerant to standard therapies, or have refused standard therapy;
• ECOG: 0-1;
• Adequate organ and bone marrow function;
• sign an informed consent.

You may not qualify if:

• Patients with brain malignant tumor or active CNS metastasis;
• UGT1A1\*28 homozygous mutants;
• Clinically significant GI disorders;
• Significant cardiovascular disease;
• Active infection or uncontrolled fever;
• Pregnant or breast feeding patients;
• Allergic to a drug ingredient or component;
• The investigators determined that other conditions were inappropriate for participation in this clinical trial.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• Ji D, Shen W, Li T, Wang H, Bai J, Cao J, Hu X. Liposomal irinotecan (HR070803) in combination with 5-fluorouracil and leucovorin in patients with advanced solid tumors: a phase 1b dose-escalation and expansion study. Invest New Drugs. 2024 Aug;42(4):462-470. doi: 10.1007/s10637-024-01442-2. Epub 2024 Jul 22.

  PMID: 39037543 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: a dose-escalation and expansion study

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 21, 2021
• Study Start: May 5, 2016
• Primary Completion: June 6, 2018
• Study Completion: June 6, 2018
• Last Updated: October 21, 2021

Record last verified: 2021-09

Locations

CN (1)