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In an open label, phase 1 trial, ABBV-706, an antibody\u2212drug conjugate with a SEZ6-directed antibody linked to topoisomerase-1 inhibitor (Top1i), was administered intravenously every 3\u2009weeks (Q3W) to 288 patients with advanced solid tumors; 240 received monotherapy, including 124 with relapsed\/refractory (R\/R) SCLC. Primary objectives of dose escalation (part 1, advanced solid tumors), dose optimization and expansion (part 2, R\/R SCLC only) and dose expansion (part 4, central nervous system tumors and high-grade neuroendocrine neoplasms only) were to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity and antitumor activity of ABBV-706 monotherapy and, from parts 1 and 2, to determine the recommended phase 2 dose (RP2D) of ABBV-706 in R\/R SCLC. In the monotherapy cohort (\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u2009240), the most common treatment-related adverse events (TRAEs) at any grade were anemia (61%) and fatigue (38%). Grade 3 or higher TRAEs occurred in 61% of patients and were dose dependent (39% at 1.8\u2009mg kg\n                    <jats:sup>\u22121<\/jats:sup>\n                    and 70% at 2.5\u2009mg\u2009kg\n                    <jats:sup>\u22121<\/jats:sup>\n                    ). In the R\/R SCLC monotherapy cohort (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009124), any-grade and grade 3 or higher TRAEs occurred in 93% and 61% of patients, respectively. ABBV-706 demonstrated promising preliminary efficacy in patients with R\/R SCLC, with an objective response rate (ORR) of 52% (65\/124). In patients with R\/R SCLC receiving monotherapy in dose optimization and expansion part 2, ORR was similar between 1.8\u2009mg\u2009kg\n                    <jats:sup>\u22121<\/jats:sup>\n                    and 2.5\u2009mg\u2009kg\n                    <jats:sup>\u22121<\/jats:sup>\n                    doses (56% (23\/41) and 59% (23\/39), respectively), with a duration of response that was highest at the 1.8\u2009mg\u2009kg\n                    <jats:sup>\u22121<\/jats:sup>\n                    dose and with most patients achieving rapid and durable tumor reduction. Although exploratory, long-term efficacy measures were an important consideration in the RP2D determination, and in R\/R SCLC monotherapy, overall survival (OS) was highest at the 1.8\u2009mg\u2009kg\n                    <jats:sup>\u22121<\/jats:sup>\n                    dose, with a median OS of 12.4\u2009months. Based on the totality of available data, including, but not limited to, safety, preliminary efficacy measures and PK, 1.8\u2009mg\u2009kg\n                    <jats:sup>\u22121<\/jats:sup>\n                    Q3W was confirmed as the optimal RP2D for patients with R\/R SCLC. ClinicalTrials.gov:\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\/study\/NCT05599984\" ext-link-type=\"uri\">NCT05599984<\/jats:ext-link>\n                    .\n                  <\/jats:p>","DOI":"10.1038\/s41591-026-04452-0","type":"journal-article","created":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T20:01:40Z","timestamp":1780344100000},"page":"2898-2908","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["SEZ6-targeting antibody\u2212drug conjugate ABBV-706 in advanced small cell lung cancer and solid tumors: a phase 1 trial"],"prefix":"10.1038","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0780-2677","authenticated-orcid":false,"given":"Lauren 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B.C.C.: royalties: Champions Oncology, Crown Bioscience and Imagen; research funding: MOGAM Institute, LG Chem, Oscotec, Interpark Bio Convergence Corp., GI Innovation, GI Cell, Abion, AbbVie, AstraZeneca, Bayer, Blueprint Medicines, Boehringer Ingelheim, Champions Oncology, CJ Bioscience, CJ Blossom Park, Cyrus, Dizal Pharma, Genexine, Janssen, Lilly, Merck Sharp & Dohme, Novartis, Nuvalent, Oncternal, Ono Pharmaceutical, Regeneron, Dong-A ST, Bridge Biotherapeutics, Yuhan, ImmuneOncia, Illumina, KANAPH Therapeutics, Therapex, J INTS BIO, Hanmi and CHA Bundang Medical Center; consulting: Abion, BeiGene, Novartis, AstraZeneca, Boehringer Ingelheim, Roche, Bristol Myers Squibb, CJ Bioscience, CureLogen, Cyrus Therapeutics, Ono Pharmaceutical, Onegene Biotechnology, Yuhan, Pfizer, Lilly, GI Cell, Guardant, HK inno.N, Imnewrun Biosciences, Janssen, Takeda, Merck Sharp & Dohme, Janssen, MedPacto, Blueprint Medicines, Rand Bioscience and Hanmi; employment: Yonsei University Health System; advisory boards: KANAPH Therapeutics, BridgeBio Therapeutics, Cyrus Therapeutics, Guardant Health and Oscotec; speaker: American Society of Clinical Oncology, AstraZeneca, Guardant, Roche, European Society for Medical Oncology, International Association for the Study of Lung Cancer, Korean Cancer Association, Korean Society of Medical Oncology, Korean Society of Thyroid-Head and Neck Surgery, Korean Cancer Study Group, Novartis, Merck Sharp & Dohme, Chinese Thoracic Oncology Society and Pfizer; stocks\/shares: TherCanVac, Gencurix, Bridge Biotherapeutics, KANAPH Therapeutics, Cyrus Therapeutics, Interpark Bio Convergence Corp. and J INTS BIO; founder of DAAN Biotherapeutics; member of the board of directors: Interpark Bio Convergence Corp. and J INTS BIO. A.J.C.: honoraria: CancerGRACE, MJH Life Sciences, IDEOlogy Health, Intellisphere and MedStar Health; consulting\/advisory fees: AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Gilead Sciences, Novartis and Regeneron; research funding (to the institution, end August 2025): Merck, Monte Rosa Therapeutics, AbbVie, Roche, Daiichi Sankyo and Amgen. A.C.C.: institutional research funding: AbbVie, AstraZeneca, Bristol Myers Squibb, Amgen, GNE, Zai Lab and Oryzon; advisory boards\/consulting: AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Fosun Pharma, GNE, Janssen, Merck and Zai Lab; data and safety monitoring committee: AstraZeneca. J.-Y.H.: honoraria: AstraZeneca, Janssen, Merck, Novartis, Pfizer, Takeda and Yuhan; consulting or advisory role: AbbVie, Amgen, AstraZeneca, Daiichi Sankyo\/UCB Japan, Janssen, Lantern Pharma, Merck, Novartis, Oncovix and Takeda; research funding: Pfizer and Roche. M.F.: research funding (to the institution): AbbVie, Amgen, Aprea, Astellas, AstraZeneca, BeOne Medicines, BioNTech, Bristol Myers Squibb, Checkmate, Day One Biopharmaceutical, Elicio, Genmab, Genentech, Gilead, GlaxoSmithKline, Immunocore, Incyte, Inhibrx, Jacobio, Lilly, Merck, Mirati Therapeutics, Novartis, Poseida and Systimmune; consultant: Omega Therapeutics and Novartis; advisory board: AbbVie, AstraZeneca, Jazz Pharmaceuticals and Mirati Therapeutics. A.D.: advisory board: AstraZeneca, Pfizer, Puma Biotechnology, Amgen and AbbVie. D.M.: advisor: Bristol Myers Squibb, AbbVie, Natera, Boehringer Ingelheim, Bayer, Johnson & Johnson and Tubulis; received institutional research funding from Merck, Celgene, AstraZeneca, Baxter, Incyte, AbbVie, Bristol Myers Squibb, Pfizer, Roche, Lilly, Array BioPharma, Surface Oncology, Arcus Biosciences, Boehringer Ingelheim, Y-mAbs Therapeutics, Tubulis and NextCure. K.P.P.: consulting\/advisory role: Turning Point Therapeutics and AADi; research funding (to the institution): AbbVie, Daiichi Sankyo, Regeneron, Amgen, Incyte, Merck, 3D Medicines, Syros Pharmaceuticals, Mersana, MabSpace Biosciences, Jounce Therapeutics, Bayer, Anheart Therapeutics, F-Star, Linnaeus Therapeutics, Mirati Therapeutics, Tempest Therapeutics, Treadwell Therapeutics, Lilly, Pfizer, BioNTech, Bicycle Therapeutics, Kezar Life Sciences, AstraZeneca, CytomX Therapeutics, Debiopharm Group, Monte Rosa Therapeutics, PharmaMar, Revolution Medicines, Sensei Biotherapeutics, Storm Therapeutics, Parabilis Medicines, Genmab, Bristol Myers Squibb\/Celgene, Alnylam and Frontier Medicines. N.C.: institutional research funding: Amgen, AbbVie, Monte Rosa Therapeutics, Roche\/Genentech, Merck, Harpoon Therapeutics, Janux Therapeutics and Seagen\/Pfizer; honoraria: MJH Life Sciences and IDEOlogy Health; royalties: Wolters Kluwer; consulting\/advisory role: AbbVie, Merck, Harpoon Therapeutics, Lilly, Daiichi Sankyo, Pfizer, Bristol Myers Squibb, Ideaya Biosciences and Amgen. M.V.: travel\/accommodation expenses: Merck, Roche and Serono; consultant: Debiopharm Group, Roche and TFS. J.B.: advisory board: AbbVie, Amgen, AstraZeneca, Bayer, BeiGene, GenMab, Janssen, Merck Sharp & Dohme, Merck Serono, Medison, Nectin Therapeutics, Roche and Takeda; writing\/speaker engagement: Bristol Myers Squibb, Medison and Pfizer; research funding (to the institution): Immunai, OncoHost, Merck Sharp & Dohme, AstraZeneca, Takeda, Roche, AbbVie, Merck, Pfizer, Lilly and Regeneron; steering committee member: Roche, AstraZeneca, AbbVie. J.-H.K.: institutional research funding: AbbVie, Bristol Myers Squibb, AstraZeneca, Takeda, BeOne Medicines, Amgen, Merck Sharp & Dohme, Merck, Roche and Yuhan. W.A.: research funding (to the institution): Bristol Myers Squibb and AstraZeneca; other relationship: Lilly. T.M.K.: consultancy: AstraZeneca, BeOne Medicines, Chong Kun Dang Pharmaceutical, Daiichi Sankyo, Daewoong Pharmaceutical, Illumina Korea, Janssen, LigaChemBio, Merck KGaA, Novartis, Regeneron, Roche\/Genentech and Samsung Bioepis; honoraria: AstraZeneca\/MedImmune, Amgen, BeOne Medicines, Daiichi Sankyo, Janssen Research & Development and Takeda. Y.-C.K.: consulting\/advisory role: Takeda, Janssen and AstraZeneca; honoraria: AstraZeneca, Takeda, Novartis, Merck, Janssen, Pfizer and Yuhan; research funding: AstraZeneca. L.P.-A.: honoraria: AbbVie, Astellas, Boehringer Mannheim, Gilead, AstraZeneca, Janssen, Lilly, Merck Sharp & Dohme, Roche, PharmaMar, Merck, AstraZeneca, Novartis, Amgen, Pfizer, Sanofi, Bayer, Bristol Myers Squibb, GlaxoSmithKline, Janssen, Takeda, Daiichi Sankyo and Regeneron; grants to institution: Merck Sharp & Dohme, AstraZeneca, Pfizer, Bristol Myers Squibb, PharmaMar and Roche; co-founder and board member: Altum Sequencing and STAb Therapeutics. M.-J.A.: personal\/consulting fees: Alpha Pharmaceuticals, Amgen, AstraZeneca, Genexine and Pfizer; payment or honoraria: Amgen, AstraZeneca, Arcus Bioscience, Bayer, Daiichi Sankyo, Janssen Pharmaceuticals, Merck, Merck Sharp & Dohme, Roche, Takeda, Voroni and Yuhan. H.Y.: honoraria: AstraZeneca; institutional research funding: AstraZeneca, Bristol Myers Squibb, Sanofi, Takeda, Chugai Pharmaceutical Co., Merck Sharp & Dohme, Amgen, AbbVie and Daiichi Sankyo. D.M., W.M., O.O., S.W., C.F., F.J.K., P.H., T.P., G.R. and N.J.: employees of AbbVie and may own stock. R.R.R.: former employee of AbbVie (active employee at time study was conducted) and may own stock. S.C.: research funding (to the institution): AbbVie, Arvinas, Adcentrx Therapeutics, Amgen, AstraZeneca, Cardiff Oncology, Chugai Pharmaceutical Co., BioNTech, Bristol Myers Squibb, Dicephera, Elevation Oncology, Exact Sciences, Genentech, Halda Therapeutics, IDEAYA Biosciences, IGM Biosciences, Incyte Pharma, Johnson & Johnson, Qualigen Therapeutics, Mirati Therapeutics, Merck, Monte Rosa Pharmaceuticals, Rondo Therapeutics, Tizona Therapeutics, Exelexis, Ipsen, Novocure, Medilink Therapeutics and ZymeWorks; speakers bureau: Natera; advisory board: Novocure and Ipsen.","order":1,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Ethics"}}]}}