Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, and clinical activity of OBI-3424 in patients with advanced or metastatic solid tumors.

ABSTRACT:

Background

Report of a Phase 1 dose-escalation study of OBI-3424 monotherapy in patients with advanced solid tumors (NCT03592264).

Methods

A classic 3 + 3 design was used to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of OBI-3424 administered intravenously, as a single agent, at doses of 1, 2, 4, 6, 8, or 12 mg/m² (days 1 and 8 of a 21-day cycle, Schedule A) or 8, 10, 12, or 14 mg/m² (day 1 of a 21-day cycle, Schedule B).

Results

Dose-limiting hematologic toxicities at 12 mg/m² in Schedule A led to dose and schedule modifications (Schedule B). In Schedule B, maximum tolerated dose was not reached at the maximum dose tested (14 mg/m²). Grade ≥3 anemia was noted in 3/6 patients treated at 14 mg/m

SUBMITTER: Tsimberidou AM 

PROVIDER: S-EPMC10180615 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature