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Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)
Trial Status: active
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.
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07038343.
Locations matching your search criteria
United States
District of Columbia
Washington
MedStar Georgetown University Hospital
Status: Active
Name Not Available
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Approved
Name Not Available
Pennsylvania
Philadelphia
Thomas Jefferson University Hospital
Status: Active
Name Not Available
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Approved
Name Not Available
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.
