{"doi":"10.1200/jco.2020.38.4_suppl.129","title":"Phase I with expansion cohorts in a study of NEO-201 in adults with chemo-resistant solid tumors.","abstract":"129 Background: NEO-201 is a humanized IgG1 monoclonal antibody (mAb) generated against tumor-associated antigens (TAA) from colorectal cancer. Our preclinical data demonstrated that NEO-201 exerts anti-tumor activity by NK-mediated ADCC and CDC against several tumor types. We identified NEO-201 antigen as a tumor-associated form of CEACAM-5 and -6, which is expressed by tumor tissue but is not present in the surrounding healthy tissue. Methods: This is a first-in-human phase 1 study to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of NEO-201 in adults with advanced solid tumors that have high likelihood of expression NEO201 antigen and have progressed to standard of treatments. This is a classic 3+3 dose escalation, with cohort expansion at the MTD. NEO-201 is administered intravenously every two weeks, and at four dose levels (DL1 = 1mg/kg, DL2 = 2mg/kg, DL3 = 4mg/kg and DL4 = 6mg/kg). Patients are evaluated for safety according to CTCAEv5.0., and for response according to RECISTv1.1. Biological samples are collected to understand NEO-201 pharmacokinetics, the effects on immune profile and the correlation with treatment toxicity and response. Results: Here we report the safety data and pharmacokinetics from DL1 and 2. A total of 9 evaluable patients were enrolled. Prolonged neutropenia, defined as ³G2 neutropenia lasting for >7 days, was observed at DL2. The cohort was expanded to a total of 6 patients and no further DLTs were observed. Seven out of nine of the patients enrolled had colon cancer, two had pancreatic cancer and one had hormone positive breast cancer. The most frequent treatment-related AEs were infusion reaction which was observed in all patients, and moderate fatigue (33%). Best response was SD observed in two patients (one on each of DL1 and DL2). Dose escalation continues on DL3 and DL4. NEO201 antigen expression in patient tumor tissue, circulating CEACAM6/CEACAM5, and MICA will be evaluated to correlate with response and toxicity. Conclusions: NEO201 has shown some promising activity. PK and PD studies are ongoing to better understand dosing schedule, toxicity profile and to identify biomarkers for patient selection. Clinical trial information: NCT03476681.","journal":"Journal of Clinical Oncology","year":2020,"id":124504,"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":0.9641,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":569137,"name":"Nicole Houston","orcid":"0000-0001-8265-6617","position":1,"is_corresponding":false},{"id":569630,"name":"Stan Lipkowitz","orcid":null,"position":2,"is_corresponding":false},{"id":233753,"name":"Jung Min Lee","orcid":"0000-0002-8033-0725","position":3,"is_corresponding":false},{"id":561183,"name":"Alexandra Dos Santos Zimmer","orcid":null,"position":4,"is_corresponding":false},{"id":569631,"name":"Farah Zia","orcid":null,"position":5,"is_corresponding":false},{"id":569632,"name":"Kathrine Trewhitt","orcid":null,"position":6,"is_corresponding":false},{"id":242499,"name":"E. Hitt Nichols","orcid":"0009-0008-7357-4896","position":7,"is_corresponding":false},{"id":569633,"name":"Mira Pavelova","orcid":null,"position":8,"is_corresponding":false},{"id":237304,"name":"Stephen M. Hewitt","orcid":"0000-0001-8283-1788","position":9,"is_corresponding":false},{"id":423741,"name":"Massimo Fantini","orcid":"0000-0002-8164-2587","position":10,"is_corresponding":false},{"id":425136,"name":"Philip M. Arlen","orcid":null,"position":11,"is_corresponding":false},{"id":425137,"name":"Kwong Y. Tsang","orcid":null,"position":12,"is_corresponding":false},{"id":230687,"name":"Christina M. Annunziata","orcid":"0000-0003-2033-6532","position":13,"is_corresponding":false},{"id":423737,"name":"Maria Pia Morelli","orcid":"0009-0000-9543-6584","position":0,"is_corresponding":true}],"reference_count":0,"raw_metadata":null,"created_at":"2026-07-18T23:15:07.789881Z","pmid":null,"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":[]}