{"doi":"10.1007/s00280-024-04714-z","title":"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","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.","journal":"Cancer Chemotherapy and Pharmacology","year":2024,"id":462284,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":2,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9542,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":254338,"name":"Axel Grothey","orcid":"0000-0002-9341-6499","position":1,"is_corresponding":false},{"id":860814,"name":"Darren Sigal","orcid":"0000-0001-7839-1230","position":2,"is_corresponding":false},{"id":1258811,"name":"Heinz-Josef Lenz","orcid":null,"position":3,"is_corresponding":false},{"id":441217,"name":"Howard S. Höchster","orcid":"0000-0002-9893-1529","position":4,"is_corresponding":false},{"id":1184172,"name":"Yee Chao","orcid":"0000-0001-5578-340X","position":5,"is_corresponding":false},{"id":1145448,"name":"Li‐Yuan Bai","orcid":"0000-0001-7739-4077","position":6,"is_corresponding":false},{"id":1292140,"name":"Chia-Jui L Yen","orcid":null,"position":7,"is_corresponding":false},{"id":226398,"name":"Dong Xu","orcid":"0000-0002-7772-9479","position":8,"is_corresponding":false},{"id":1292141,"name":"M. Wayne Saville","orcid":null,"position":9,"is_corresponding":false},{"id":108756,"name":"Apostolia M. Tsimberidou","orcid":"0000-0003-2713-233X","position":0,"is_corresponding":true}],"reference_count":17,"raw_metadata":null,"created_at":"2026-07-19T02:04:20.631898Z","pmid":"39311947","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}