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)
Solid Tumor
Unknown Primary
18 - 75 Years, Male and Female
AVZO-1418-1001 (primary)
NCI-2025-07534
Summary
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.
Objectives
This first-in-human, Phase 1/2 study will aim to obtain safety and tolerability data when
AVZO-1418 is administered intravenously to patients with locally advanced or metastatic
epithelial solid tumors.
Phase 1 is a dose escalation phase which will assess the safety and tolerability of
AVZO-1418 and determine the maximum tolerated dose (MTD) and preliminary recommended
Phase 2 dose (RP2D) of AVZO-1418 as a monotherapy. This data can guide selection of
combination schedules and agents.
Phase 2 is a dose expansion phase that will aim to assess the antitumor activity of
AVZO-1418 as a monotherapy and potentially in combination therapy.
Eligibility
- 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.
- Patients with histologically or cytologically confirmed locally advanced/metastatic malignancies for tumor types of preferred indications: o Locally advanced or metastatic epithelial solid tumors (as specified in the protocol).
- 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. Key
Treatment Sites in Georgia
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