Clinical Trial Details
A Phase 1/2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors
Overview
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
| Ages | 18 Years - 75 Years |
| Sex | All |
| Healthy Volunteers | No |
| Age Groups | Adult, Older Adult |
Key Inclusion Criteria
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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.
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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).
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Measurable disease as assessed by Investigator using RECIST v1.1.
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Agree to provide molecular test report results to confirm eligibility and archival tumor samples and/or fresh biopsy, as applicable.
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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.
