NCT04128423

Study of AMV564 in Subjects With Advanced Solid Tumors

A Phase 1 Dose Escalation With Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMV564 Alone and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Amphivena Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 1 study is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of AMV564 alone and in combination with Pembrolizumab in patients with advanced solid tumors.

Detailed description

AMV564-301 is a Phase 1, open-label, multicenter dose-escalation with expansion trial in patients with locally advanced or metastatic solid tumors. In the dose-escalation portion of the study, cohorts of patients will receive AMV564 alone or in combination with Pembrolizumab at increasing dose levels to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion. In the expansion portion of the study, one or more cohorts of patients will receive AMV564 at the MTD or recommended dose to further evaluate safety, tolerability, and clinical activity.

Conditions

• Locally Advanced or Metastatic Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	AMV564	AMV564 will be administered daily

Timeline

• Start date: 2019-10-09
• Primary completion: 2021-12-15
• Completion: 2021-12-31
• First posted: 2019-10-16
• Last updated: 2021-10-19

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study