ALG.APV-527 First-in-human Study
brief summary
A first-in-human, multicenter, open-label, dose escalation and dose expansion phase 1 study in patients with advanced solid tumors to evaluate the safety of intravenously administered ALG.APV-527 (Short title: ALG.APV-527 first-in-human study). Adult patients with advanced/metastatic solid tumors likely to express 5T4 antigen who have failed standard of care regimens for their cancer, have become refractory to standard treatment, or for whom no effective therapy exists based on investigator judgment may be enrolled in this study. Part 1 (Dose Escalation): Approximately 36 evaluable patients planned to be enrolled. Part 2 (Dose Expansion): Approximately 20 evaluable patients planned to be enrolled.
detailed description
This first-in-human study is an open-label, multicenter, Phase 1 study with the aim to assess safety and tolerability and preliminary anti-tumor activity of ALG.APV-527 administered intravenously to patients with advanced solid tumor malignancies. Patients will be required to provide tumor tissue biopsy material that has been obtained within 28 days prior to the first dose of study drug ALG.APV-527.
The trial has 2 parts, Part 1 (Dose Escalation) and Part 2 (Dose Expansion). The Escalation Phase (Part 1) is projected to occur in 6 patient cohorts of increasing dose levels and will explore the Maximum Tolerated Dose (MTD) and/or the RP2D. Part 1 consists of a 3 + 3 dose-escalation examination of ALG.APV-527 single agent therapy in adult patients with RECIST Version1.1-measurable advanced solid tumors.
The MTD is defined as the highest dose level that has 6 patients evaluable for DLT with no more than 1 of 6 with DLT.
Part 2 (Dose Expansion):
Part 2 consists of a single agent evaluation of the safety and clinical activity of ALG.APV-527 at its RP2D in up to 20 patients with advanced solid tumors. Part 2 will commence after all tested dose levels have been reviewed and a RP2D has been determined.
Primary Objectives:
Primary (Dose Escalation)
* To determine the safety, tolerability, MTD of ALG.APV-527 administered intravenously as single agent therapy * To designate an IV dose level for the Dose Expansion Phase (RP2D) of ALG.APV-527 administered IV as single agent therapy for patients with advanced solid tumors. The RP2D can be different from the MTD.
Primary (Dose Expansion)
• To further evaluate the safety and tolerability of ALG.APV-527 when administered intravenously at the RP2D level as monotherapy in patients with advanced solid tumors
official title
A First-in-human, Multicenter, Open-label, Dose Escalation and Dose Expansion Phase 1 Study in Patients With Advanced Solid Tumors to Evaluate the Safety of Intravenously Administered ALG.APV-527