Phase I-II Study of OBI-888, a Humanized Monoclonal IgG1 Antibody Against the Tumor-associated Carbohydrate Antigen Globo H, in Patients with Advanced Solid Tumors

Overview

Journal Cancer Chemother Pharmacol

Specialty Oncology

Date 2024 Sep 23

PMID 39311947

Authors

Apostolia Maria Tsimberidou

Axel Grothey

Darren Sigal

Heinz-Josef Lenz

Howard S Hochster

Yee Chao

Li-Yuan Bai

Chia-Jui L Yen

Dong Xu

M Wayne Saville

Affiliations

Soon will be listed here.

Abstract

Purpose: OBI-888 is a humanized, monoclonal IgG1 antibody specific to the tumor-associated carbohydrate antigen Globo H. We conducted a phase I-II study of OBI-888 in patients with advanced cancer.

Methods: Patients were treated with OBI-888 5, 10, or 20 mg/kg IV weekly in Part A ("3 + 3" design) and 20 mg/kg IV weekly in Part B (Simon's 2-stage design) (1 cycle = 28 days).

Results: Overall, 54 patients were treated (Part A, n = 14; Part B, n = 40). OBI-888 was safe and well tolerated across the doses studied, with a low incidence of OBI-888-related treatment emergent adverse events. The maximum tolerated dose of OBI-888 was not reached. No dose-limiting toxicities were noted up to the 20 mg/kg dose level (recommended phase 2 dose). Stable disease (SD) was noted in 28.6% and 20% of Parts A and B, respectively, including three patients with SD for 6+, 7+, and 9 months. Antibody-dependent cellular cytotoxicity (ADCC) was induced after each OBI-888 treatment (average increase, 3.8-fold and 4.7-fold in Parts A and B, respectively), suggesting that ADCC induction is a potential mechanism of action of OBI-888.

Conclusions: OBI-888 was well tolerated. Prolonged SD was noted in three patients. ADCC was induced after each OBI-888 treatment.

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