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

Launched by AVENZO THERAPEUTICS, INC. · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new drug called AVZO-1418 to see if it is safe and effective in treating certain types of advanced cancers, including lung and other solid tumors that have spread or cannot be removed by surgery. The study will look at how the drug works alone and possibly combined with other treatments, and will help doctors understand the best dose to give patients. This is an early-stage trial, so the main focus is on safety and how the body handles the drug, but researchers will also look for signs that the drug can help shrink tumors.

Adults with confirmed advanced solid tumors who are generally in good health (able to carry out daily activities with minimal assistance) and have a life expectancy of more than three months may be eligible. Patients must have measurable tumors and be willing to provide information from molecular tests or tumor samples. People with certain conditions, such as uncontrolled high blood pressure, active brain cancer spread, serious heart problems, or recent severe infections, may not qualify. If you join the trial, you can expect to receive the drug through an IV and have regular check-ups to monitor your health and how the treatment is working. This study is currently looking for participants and aims to find new options for patients with difficult-to-treat cancers.

Gender

ALL

Eligibility criteria

• • Key Inclusion Criteria
• • Patient must be an adult, 18 years of age and older 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.