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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04128423
• Other study ID #: AMV564-301
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: October 9, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2021
• Source: Amphivena Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: December 31, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced or Metastatic Solid Tumors
• Neoplasms

Intervention

Biological:
• AMV564
AMV564 will be administered daily

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	The Christ Hospital	Cincinnati	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	MD Anderson Cancer Center	Houston	Texas
United States	UCLA	Los Angeles	California
United States	Peninsula Cancer Institute	Newport News	Virginia
United States	Advent Health	Orlando	Florida
United States	NEXT Oncology	San Antonio	Texas
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Amphivena Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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