biostudies-literatureMorgensztern DNCATS NIH HHSNCI NIH HHS5042-5052https://www.ebi.ac.uk/biostudies/studies/S-EPMC11565168biostudies-literatureUnknown30(22)<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 = 3Clinical cancer research : an official journal of the American Association for Cancer ResearchA 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.PMC11565168P30 CA177558P30 CA008748P30 CA086862P30 CA093373UL1 TR001863Carbone DPJohnson MLMorgensztern DChoudhury NJeng EEAkamatsu HNosaki KIams WKozuki TMurakami HWang SDowlati AZha JYokouchi HPuri SSantana-Davila RLi RArnold SMReady NFurqan MTolcher ALi THingorani PHegde ARobinson RRChiang ACPiotrowska ZSchaefer EfalseA 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.<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 = 32024-01-01T00:00:00Z2024 Nov2026-06-03T03:12:57.552Z2025-04-06T22:42:51.022ZS-EPMC115651683928782110.1158/1078-0432.CCR-24-1547