NCT04659096

A Study of ION537 in Patients With Molecularly Selected Advanced Solid Tumors

Phase 1 Trial of ION537 in Patients With Molecularly Selected Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and establish the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of ION537 when administered by intravenous infusion in patients with advanced solid tumors.

Detailed description

This is a single center, open label, non-randomized, Phase 1, two-part study of ION537 in up to 102 participants. Part 1 of the study consists of sequential cohort, dose escalation in patients with advanced solid tumors. Part 2 is dose expansion in patients with molecularly selected advanced solid tumors. In total, the study includes up to 102 participants. The study will consist of a 30-day screening period, a treatment period consisting of sequential consecutive treatment cycles (each cycle will be of 28 days) and a post-treatment follow-up period of at least 28 days following the last dose of study drug.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	ION537	ION537 will be administered by IV injection.

Timeline

• Start date: 2021-01-05
• Primary completion: 2022-10-19
• Completion: 2022-10-19
• First posted: 2020-12-09
• Last updated: 2022-12-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study