Open
Actively Recruiting
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)
About
Brief 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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Key Inclusion Criteria
- 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 Exclusion Criteria
- 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.
- Infection requiring IV antibiotics, antivirals, or antifungals within 2 weeks prior to first dose.
- History of a solid organ transplant.
* Other protocol-defined Exclusion criteria apply.
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Study Stats
Protocol No.
26-0423
Category
Bladder Cancer
Breast Cancer
Head and Neck Cancer
Lung Cancer
Other Cancer
Principal Investigator
Contact
- Joanna Gutierrez
Location
- UCLA Santa Monica