Evidence Level:Sensitive: C3 – Early Trials
Title:
Safety, pharmacokinetics, and clinical activity of OBI-3424, an AKR1C3‑activated prodrug, in patients with advanced or metastatic solid tumors: A phase 1 dose-escalation study.
Excerpt:OBI-3424 showed linear pharmacokinetics from 1 to 14 mg/m2, with minimal accumulation after repeated dosing. A retrospective validated automated immunohistochemistry assessment indicated that 27% of patients had high AKR1C3 staining (H-score ≥135). Best confirmed response was stable disease in 21 patients (54%). We completed the dose-escalation portion of the study. The RP2D was determined to be 12 mg/m2 once every 3 weeks. OBI-3424 was well tolerated. Dose-dependent, non-cumulative thrombocytopenia and anemia were dose limiting.
DOI:10.1200/JCO.2022.40.16_suppl.3030