A Phase 1, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AB0024 in Adult Patients With Advanced Solid Tumors
This is a first-in-human, open-label, sequential dose escalation study to evaluate AB0024 in
patients with advanced solid tumors. The study will consist of two parts: Part A will be a
dose escalation, and Part B will be a dose expansion.The primary objective of this study is
to characterize the safety, tolerability, and PK of AB0024 after multiple IV administrations
in patients with advanced solid tumors. The secondary objectives are to measure the tumor
response by modified RECIST and to evaluate the formation of anti-AB0024 antibodies.
Patients will receive infusions of AB0024 every two weeks. Patients will be seen weekly for
safety assessments and collection of blood samples. Patients who do not show evidence of
disease progression by clinical assessment or by CT or MRI may continue receiving AB0024
every 2 weeks until disease progression (clinical or radiographic), study drug intolerance,
or withdrawal of consent.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To characterize the safety, tolerability, and pharmacokinetics (PK) of AB0024 after multiple intravenous (IV) administrations in patients with advanced solid tumors.
Patricia LoRusso, DO
Karmanos Cancer Institute
United States: Food and Drug Administration
|Karmanos Cancer Institute||Detroit, Michigan 48201|
|South Texas Accelerated Research Therapeutics||San Antonio, Texas 78229|