First-in-Human Study of OBI-999, a Globo H-Targeting Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors.

ABSTRACT:

Purpose

OBI-999 is a novel antibody-drug conjugate comprising the Globo H-targeting antibody (OBI-888) linked to the cytotoxic payload monomethyl auristatin E. OBI-999 demonstrated excellent dose-dependent tumor growth inhibition in breast, gastric, and pancreatic cancer xenograft models as well as a lung cancer patient-derived xenograft model. We conducted a phase I study of OBI-999 monotherapy in patients with advanced cancer (ClinicalTrials.gov identifier: NCT04084366).

Patients and methods

OBI-999 was administered intravenously at doses of 0.4, 0.8, 1.2, and 1.6 mg/kg every 21 days as part of a 3 + 3 trial design. Primary end points were the incidence of dose-limiting toxicities and adverse events and determination of the maximum tolerated dose (MTD)/recommended phase II

SUBMITTER: Tsimberidou AM 

PROVIDER: S-EPMC9929104 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature