Clinical trial NCT04128423: Study of AMV564 in Subjects With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Locally Advanced or Metastatic Solid Tumors
Keywords: immunotherapy
anti-CD33
T-cell engager
Lead sponsor: Amphivena Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-16
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Treatment-Related Adverse Events
timeFrame: Through study completion, an average of 19 months
measure: Maximum tolerated dose of AMV564 in subjects with advanced solid tumors
timeFrame: During Dose Escalation, an average of 6 months
measure: Preliminary evaluation of AMV564 efficacy in subjects enrolled in the expansion phase
timeFrame: During Dose Expansion, an average of 1 year
Secondary outcomes:
measure: Maximum observed drug concentration (Cmax) of AMV564
timeFrame: Through study completion, an average of 19 months
measure: Concentration at steady state (Css) of AMV564
timeFrame: Through study completion, an average of 19 months
measure: Time of the maximum drug concentration (Tmax) of AMV564
timeFrame: Through study completion, an average of 19 months
measure: Apparent terminal half-life (t½) of AMV564
timeFrame: Through study completion, an average of 19 months
measure: Area under the concentration-time curve (AUC) of AMV564
timeFrame: Through study completion, an average of 19 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Orlando
country: United States
facility: Advent Health
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: NEXT Oncology
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Newport News
country: United States
facility: Peninsula Cancer Institute
state: Virginia
Study officials:
affiliation: Amphivena Therapeutics
name: Patrick Chun, MD
role: STUDY_DIRECTOR
References: