AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAvenzo Therapeutics, Inc.

About this trial

This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a monotherapy and potentially in combination therapy to patients with locally advanced or metastatic epithelial solid tumors.

Eligibility criteria

Qualifiers

Patient must be an adult, between 18 and 75 years of age with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 and a life expectancy of > 3 months.

Measurable disease as assessed by Investigator using RECIST v1.1.

Agree to provide molecular test report results to confirm eligibility and archival tumor samples and/or fresh biopsy, as applicable.

Other protocol-defined Inclusion criteria apply.

Disqualifiers

Uncontrolled hypertension.

Patients with active central nervous system (CNS) metastases are not eligible. Patients with asymptomatic and treated brain metastases may participate if they are radiologically stable for at least 4 weeks prior to the first dose of this study and do not require steroid treatment. Patients with suspected or confirmed leptomeningeal disease are not eligible, even if treated.

History of drug-induced interstitial lung disease (ILD).

History of any serious cardiovascular condition.

Trial design

Treatments tested in this trial

  • AVZO-1418
  • Combination Agent 1
  • Combination Agent 2

Treatment groups

480 Participants
are divided into 4 treatment groups

Sponsors and collaborators