Spots Global Cancer Trial Database for A Dose Escalation Study of MM-398 Plus Irinotecan in Patients With Unresectable Advanced Cancer

Study Description

Brief Summary: MM-398 (also known as PEP02) is nanoliposomal encapsulated irinotecan: the liposomal formulation is designed to extend plasma circulation and to increase accumulation in the tumor through the enhanced permeability and retention (EPR) effect. This study introduces a new concept of combining free and nanoliposomal drugs.

Detailed Description: This is a dose-finding and therapeutic exploratory phase Ib multi-center, open label study of MM-398 plus irinotecan in two different settings: * Group A : patients with unresectable advanced non-colorectal cancer who should receive only MM-398 and irinotecan * Group B : patients with unresectable metastatic colorectal cancer who should receive MM-398 and irinotecan combined with leucovorin, 5-fluorouracil and bevacizumab. These groups will be enrolling in parallel. Pharmacokinetic and biomarker sampling will also be performed. There are three periods to this study : Screening period (up to -28d): patients undergo screening assessments to determine the eligibility for the study MM-398 treatment period (C1D1 until safety evaluation/progression): patients receive treatment every 2 weeks and undergo biopsies and other required assessments. The treatment period is divided into a maximum of 3 dose levels Follow up period: patients will be followed-up 30 days after their last dose of MM-398 for final safety assessments, and every 2 months thereafter for overall survival follow-up

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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