{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Morgensztern D"],"funding":["NCATS NIH HHS","NCI NIH HHS"],"pagination":["5042-5052"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11565168"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["30(22)"],"pubmed_abstract":["<h4>Purpose</h4>Seizure-related homolog protein 6 (SEZ6) is a novel target expressed in small cell lung cancer (SCLC). ABBV-011, a SEZ6-targeted antibody conjugated to calicheamicin, was evaluated in a phase I study (NCT03639194) in patients with relapsed/refractory SCLC. We report initial outcomes of ABBV-011 monotherapy.<h4>Patients and methods</h4>ABBV-011 was administered intravenously once every 3 weeks during dose escalation (0.3-2 mg/kg) and expansion. Patients with SEZ6-positive tumors (≥25% of tumor cells with ≥1+ staining intensity by IHC) were preselected for expansion. Safety, tolerability, antitumor activity, and pharmacokinetics were evaluated.<h4>Results</h4>As of August 2022, 99 patients received ABBV-011 monotherapy [dose escalation, n = 36; Japanese dose evaluation, n = 3"],"journal":["Clinical cancer research : an official journal of the American Association for Cancer Research"],"pubmed_title":["A Phase I First-in-Human Study of ABBV-011, a Seizure-Related Homolog Protein 6-Targeting Antibody-Drug Conjugate, in Patients with Small Cell Lung Cancer."],"pmcid":["PMC11565168"],"funding_grant_id":["P30 CA177558","P30 CA008748","P30 CA086862","P30 CA093373","UL1 TR001863"],"pubmed_authors":["Carbone DP","Johnson ML","Morgensztern D","Choudhury N","Jeng EE","Akamatsu H","Nosaki K","Iams W","Kozuki T","Murakami H","Wang S","Dowlati A","Zha J","Yokouchi H","Puri S","Santana-Davila R","Li R","Arnold SM","Ready N","Furqan M","Tolcher A","Li T","Hingorani P","Hegde A","Robinson RR","Chiang AC","Piotrowska Z","Schaefer E"],"additional_accession":[]},"is_claimable":false,"name":"A Phase I First-in-Human Study of ABBV-011, a Seizure-Related Homolog Protein 6-Targeting Antibody-Drug Conjugate, in Patients with Small Cell Lung Cancer.","description":"<h4>Purpose</h4>Seizure-related homolog protein 6 (SEZ6) is a novel target expressed in small cell lung cancer (SCLC). ABBV-011, a SEZ6-targeted antibody conjugated to calicheamicin, was evaluated in a phase I study (NCT03639194) in patients with relapsed/refractory SCLC. We report initial outcomes of ABBV-011 monotherapy.<h4>Patients and methods</h4>ABBV-011 was administered intravenously once every 3 weeks during dose escalation (0.3-2 mg/kg) and expansion. Patients with SEZ6-positive tumors (≥25% of tumor cells with ≥1+ staining intensity by IHC) were preselected for expansion. Safety, tolerability, antitumor activity, and pharmacokinetics were evaluated.<h4>Results</h4>As of August 2022, 99 patients received ABBV-011 monotherapy [dose escalation, n = 36; Japanese dose evaluation, n = 3","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024 Nov","modification":"2026-06-03T03:12:57.552Z","creation":"2025-04-06T22:42:51.022Z"},"accession":"S-EPMC11565168","cross_references":{"pubmed":["39287821"],"doi":["10.1158/1078-0432.CCR-24-1547"]}}