NCT06710821

Irinotecan Liposomes Combined with Temozolomide and Vincristine in the Treatment of Pediatric Patients with Solid Tumors

Phase I Clinical Study of Irinotecan Liposomes in Combination with Temozolomide and Vincristine in the Treatment of Patients with Relapsed/refractory Pediatric Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Yizhuo Zhang · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, single-center Ia/Ib clinical study divided into two parts, including Phase Ia Dose Exploration and Phase Phase Ib Extension Phase.

Detailed description

Phase Ia dose exploration phase: Using a "3+3" study design, 15-30 eligible subjects will receive irinotecan liposome. Five dose groups of irinotecan liposome 40 mg/m2, 50 mg/m2, 65 mg/m2, 80 mg/m2, and 100 mg/m2 will be pre-determined for a 21-day cycle. The dose of liposomal irinotecan will be gradually increased from the low dose group to the high dose group, and DLT will be observed during the dosing cycle.The same subject will receive only one dose of liposomal irinotecan during the study period. All subjects will complete relevant protocol-specified investigations during the course of treatment to observe safety and initial efficacy. Phase Ib Expansion Phase: Based on the results of the Phase Ia dose-climbing phase, the Phase Ib study will be conducted at the RP dose of irinotecan liposomes, and all subjects will complete the relevant examinations specified in the protocol during treatment to observe safety, preliminary efficacy, and so on.

Conditions

• Solid Tumor Cancer

Interventions

Type	Name	Description
DRUG	Liposomal irinotecan in combination with vincristine and temozolomide	Vincristine: 1.5 mg/m², iv, d1. l Temozolomide 150 mg/m²/d, iv drip, d1-5. l Irinotecan liposomal RP dose, iv infusion over 90 min, d1. Q3W, 4 cycles expected until disease progression or intolerable toxicity occurs

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2024-11-29
• Last updated: 2024-11-29