NCT06290388

Study of 23ME-01473 in Patients With Advanced Solid Malignancies

A Phase 1/2a, Multicenter, Open-label, Dose Escalation and Expansion Study of Intravenously Administered 23ME-01473 in Participants With Advanced Solid Malignancies

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: 23andMe, Inc. · Industry
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of 23ME-01473 given by intravenous infusion in participants with advanced solid cancers who have progressed or are intolerant of available standard therapies.

Detailed description

This study includes a dose escalation portion to determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) to evaluate the clinical activity of 23ME-01473 and further evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in participants with solid malignancies.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	23ME-01473	23Me-01473 given by intravenous infusion

Timeline

• Start date: 2024-03-07
• Primary completion: 2024-11-10
• Completion: 2024-11-10
• First posted: 2024-03-04
• Last updated: 2024-12-04

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study