Study of AMV564 in Subjects With Advanced Solid Tumors

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Locally Advanced or Metastatic Solid Tumors

Intervention / Treatment
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* Biological: AMV564


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 18 years of age or older Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Histologically or cytologically documented, incurable or metastatic solid tumor that is advanced (non-resectable) or recurrent and progressing since the last anti-tumor therapy and for which no recognized standard therapy exists Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or per other criteria best suited for the specific tumor type being evaluated Willing to complete all scheduled visits and assessments at the institution administering therapy Key Exclusion Criteria: Treatment with any local or systemic antineoplastic therapy (including chemotherapy, hormonal therapy, or radiation) within 3 weeks prior to first dose of AMV564 Major trauma or major surgery within 4 weeks prior to first dose of AMV564 Prior treatment with chimeric antigen receptor (CAR) T-cell therapy or T-cell engager therapy Chronic use of corticosteroids in excess of 10 mg daily of prednisone or equivalent within 4 weeks prior to first dose of AMV564 Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 except for alopecia Known, central nervous system (CNS) disease involvement, or prior history of National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Grade ≥ 3 drug-related CNS toxicity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMV564<br> | Biological: AMV564<br>* AMV564 will be administered daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Related Adverse Events | As measured by the incidence, nature and severity of adverse events (AEs) and serious AEs | 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 | 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) | During Dose Expansion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed drug concentration (Cmax) of AMV564 | Measured by plasma concentration | Through study completion, an average of 19 months | 
| Concentration at steady state (Css) of AMV564 | Measured by plasma concentration | Through study completion, an average of 19 months | 
| Time of the maximum drug concentration (Tmax) of AMV564 | Measured by plasma concentration | Through study completion, an average of 19 months | 
| Apparent terminal half-life (t½) of AMV564 | Measured by plasma concentration | Through study completion, an average of 19 months | 
| Area under the concentration-time curve (AUC) of AMV564 | Measured by plasma concentration | Through study completion, an average of 19 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunotherapy, anti-CD33, T-cell engager