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Trial NCT07038343

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)

Phase
Phase 1/2
Sponsor
Avenzo Therapeutics, Inc.
Conditions
Solid Tumor Cancer; Locally Advanced; Metastatic Solid Tumors; Lung Cancers; Epithelial Tumor; Biliary Tract Cancer (BTC); Urothelial Cancer; Nasopharyngeal Cancers
Ages
18–75 years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

Key Inclusion Criteria * Patient must be an adult, between 18 and 75 years of ageAge with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1Performance status 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.Brain metastases * 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.

Restrictions found (3)

Recruiting in Massachusetts

  • Avenzo Therapeutics Recruiting Site · Boston, Suffolk County