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Study of AMV564 in Subjects With Advanced Solid Tumors

Locally Advanced or Metastatic Solid Tumors Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Locally Advanced or Metastatic Solid Tumors
  • Neoplasms
Clinical Trial Details
NCT number NCT04128423
Study type Interventional
Source Amphivena Therapeutics, Inc.
Contact
Status Active, not recruiting
Phase Phase 1
Start date October 9, 2019
Completion date December 31, 2021
View Details
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