A Phase 1 interventional study of AMV564 in Locally Advanced or Metastatic Solid Tumors, sponsored by Amphivena Therapeutics, Inc.. Status unknown at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-19.
Sponsored by Amphivena Therapeutics, Inc. · Phase 1, Interventional, and Treatment
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 65 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Amphivena Therapeutics, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Biological: AMV564
AMV564 will be administered daily
Incidence of Treatment-Related Adverse Events
As measured by the incidence, nature and severity of adverse events (AEs) and serious AEs
Time frame: Through study completion, an average of 19 months
Maximum tolerated dose of AMV564 in subjects with advanced solid tumors
As determined based on the occurrence of dose-limiting toxicity
Time frame: During Dose Escalation, an average of 6 months
Preliminary evaluation of AMV564 efficacy in subjects enrolled in the expansion phase
As measured by the objective response rate (ORR)
Time frame: During Dose Expansion, an average of 1 year
Maximum observed drug concentration (Cmax) of AMV564
Measured by plasma concentration
Time frame: Through study completion, an average of 19 months
Concentration at steady state (Css) of AMV564
Measured by plasma concentration
Time frame: Through study completion, an average of 19 months
Time of the maximum drug concentration (Tmax) of AMV564
Measured by plasma concentration
Time frame: Through study completion, an average of 19 months
Apparent terminal half-life (t½) of AMV564
Measured by plasma concentration
Time frame: Through study completion, an average of 19 months
Area under the concentration-time curve (AUC) of AMV564
Measured by plasma concentration
Time frame: Through study completion, an average of 19 months
Plan to share: No
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This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Amphivena Therapeutics, Inc.