{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T02:41:45Z","timestamp":1793155305867,"version":"4.5.0"},"reference-count":46,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2026,5,22]],"date-time":"2026-05-22T00:00:00Z","timestamp":1779408000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,5,22]],"date-time":"2026-05-22T00:00:00Z","timestamp":1779408000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"This study was sponsored by Pfizer Inc."}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Invest New Drugs"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:sec>\n                    <jats:title>Summary<\/jats:title>\n                    <jats:p>B7-H4 is overexpressed in various cancers, making it a promising target for cancer immunotherapy. This phase 1, open-label, first-in-human study in patients with advanced\/metastatic breast, ovarian and endometrial cancer evaluates the safety, pharmacokinetics (PK), and anti-tumour activity of PF-07260437, a novel B7-H4xCD3 bispecific T-cell engager. Enrolled patients received escalating doses of PF-07260437 (with\/without priming dose) subcutaneously every two weeks, with a starting dose of 100\u00a0\u00b5g. Primary objectives included determination of maximum tolerated dose (MTD)\/recommended dose for expansion (RDE), safety and tolerability. Secondary objectives included PK parameters and immunogenicity. Bayesian logistic regression model (BLRM) was used to guide dose escalation. Thirty patients with advanced\/metastatic breast, ovarian and endometrial cancer received the study treatment during dose escalation; all were female (median age, 61.0 [41\u201375] years). Four patients (13.3%) experienced DLTs (alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, cytokine release syndrome). Overall, 29 (96.7%) patients experienced 202 treatment-related TEAEs (no grade 4\/5 TEAEs); no TEAE resulted in study discontinuation. No objective response was observed. Disease control rate (DCR) was 33.3% (95% CI: 17.3%, 52.8%). PF-07260437\u2009\u2265\u2009300\u00a0\u03bcg resulted in exposures in the theoretic efficacious range, with a transient increase in serum cytokines levels following the first dose. The study was terminated by the Sponsor based on the overall assessment of the observed clinical safety, preliminary efficacy, pharmacokinetic and pharmacodynamic data. The MTD was not reached. PF-07260437 was tolerable in patients with breast, ovarian, and endometrial cancers with manageable TEAEs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration Number<\/jats:title>\n                    <jats:p>NCT05067972.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Registration date<\/jats:title>\n                    <jats:p>5 October, 2021<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10637-026-01614-2","type":"journal-article","created":{"date-parts":[[2026,5,22]],"date-time":"2026-05-22T09:14:43Z","timestamp":1779441283000},"page":"305-316","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["A phase 1 study of PF-07260437, a B7-H4\u2009\u00d7\u2009CD3 bispecific T-cell engager, in patients with advanced or metastatic breast, ovarian, and endometrial cancer"],"prefix":"10.1007","volume":"44","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0234-4937","authenticated-orcid":false,"given":"Fengting","family":"Yan","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcia","family":"Cruz-Correa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"Specht","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward Wenge","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jinyu","family":"Lu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hatem","family":"Soliman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy","family":"Jackson-Fisher","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Szu-Yu","family":"Tang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sibo","family":"Jiang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christophe","family":"Le Corre","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meng","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Sommerhalder","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,5,22]]},"reference":[{"issue":"8","key":"1614_CR1","doi-asserted-by":"publisher","first-page":"1054","DOI":"10.1038\/s43018-023-00586-z","volume":"4","author":"RC Bargou","year":"2023","unstructured":"Bargou RC (2023) The expanding success of T cell-engaging bispecific antibodies. Nature Cancer 4(8):1054\u20131055. https:\/\/doi.org\/10.1038\/s43018-023-00586-z","journal-title":"Nature Cancer"},{"issue":"5","key":"1614_CR2","doi-asserted-by":"publisher","first-page":"552","DOI":"10.1097\/cco.0000000000000869","volume":"34","author":"PA Baeuerle","year":"2022","unstructured":"Baeuerle PA, Wesche H (2022) T-cell-engaging antibodies for the treatment of solid tumors: challenges and opportunities. Curr Opin Oncol 34(5):552\u2013558. https:\/\/doi.org\/10.1097\/cco.0000000000000869","journal-title":"Curr Opin Oncol"},{"issue":"1","key":"1614_CR3","doi-asserted-by":"publisher","first-page":"193","DOI":"10.1111\/imr.12393","volume":"270","author":"M Klinger","year":"2016","unstructured":"Klinger M, Benjamin J, Kischel R, Stienen S, Zugmaier G (2016) Harnessing T cells to fight cancer with BiTE\u00ae antibody constructs \u2013 past developments and future directions. Immunol Rev 270(1):193\u2013208. https:\/\/doi.org\/10.1111\/imr.12393","journal-title":"Immunol Rev"},{"issue":"2","key":"1614_CR4","doi-asserted-by":"publisher","first-page":"473","DOI":"10.1158\/1078-0432.Ccr-18-2337","volume":"25","author":"EY Jen","year":"2019","unstructured":"Jen EY, Xu Q, Schetter A, Przepiorka D, Shen YL, Roscoe D et al (2019) FDA Approval: blinatumomab for patients with B-cell precursor acute lymphoblastic leukemia in morphologic remission with minimal residual disease. Clin Cancer Res 25(2):473\u2013477. https:\/\/doi.org\/10.1158\/1078-0432.Ccr-18-2337","journal-title":"Clin Cancer Res"},{"issue":"18","key":"1614_CR5","doi-asserted-by":"publisher","first-page":"4035","DOI":"10.1158\/1078-0432.Ccr-15-0612","volume":"21","author":"D Przepiorka","year":"2015","unstructured":"Przepiorka D, Ko C-W, Deisseroth A, Yancey CL, Candau-Chacon R, Chiu H-J et al (2015) FDA Approval: Blinatumomab. Clin Cancer Res 21(18):4035\u20134039. https:\/\/doi.org\/10.1158\/1078-0432.Ccr-15-0612","journal-title":"Clin Cancer Res"},{"key":"1614_CR6","unstructured":"(2024) FDA approves blinatumomab as consolidation for CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia. https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-blinatumomab-consolidation-cd19-positive-philadelphia-chromosome-negative-b-cell. Accessed 30 Sept 2024"},{"key":"1614_CR7","unstructured":"(2023) FDA D.I.S.C.O. Burst Edition: FDA approval of Lunsumio (mosunetuzumab-axgb) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-disco-burst-edition-fda-approval-lunsumio-mosunetuzumab-axgb-adult-patients-relapsed-or#:~:text=On%20December%2022%2C%202022%2C%20the,more%20lines%20of%20systemic%20therapy. Accessed 30 Sept 2024"},{"issue":"11","key":"1614_CR8","doi-asserted-by":"publisher","first-page":"1229","DOI":"10.1007\/s40265-022-01749-5","volume":"82","author":"C Kang","year":"2022","unstructured":"Kang C (2022) Mosunetuzumab: First approval. Drugs 82(11):1229\u20131234. https:\/\/doi.org\/10.1007\/s40265-022-01749-5","journal-title":"Drugs"},{"key":"1614_CR9","unstructured":"(2024) FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma. https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-grants-accelerated-approval-epcoritamab-bysp-relapsed-or-refractory-follicular-lymphoma. Accessed 30 Sept 2024"},{"key":"1614_CR10","unstructured":"(2022) FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma. https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-teclistamab-cqyv-relapsed-or-refractory-multiple-myeloma. Accessed 30 Sept 2024"},{"key":"1614_CR11","unstructured":"(2023) FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma. https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-grants-accelerated-approval-talquetamab-tgvs-relapsed-or-refractory-multiple-myeloma. Accessed 30 Sept 2024"},{"key":"1614_CR12","unstructured":"(2023) FDA grants accelerated approval to glofitamab-gxbm for selected relapsed or refractory large B-cell lymphomas. https:\/\/www.fda.gov\/drugs\/drug-approvals-and-databases\/fda-grants-accelerated-approval-glofitamab-gxbm-selected-relapsed-or-refractory-large-b-cell. Accessed 30 Sept 2024"},{"issue":"2","key":"1614_CR13","doi-asserted-by":"publisher","first-page":"125","DOI":"10.2217\/imt-2020-0256","volume":"13","author":"H-D Hummel","year":"2021","unstructured":"Hummel H-D, Kufer P, Gr\u00fcllich C, Seggewiss-Bernhardt R, Deschler-Baier B, Chatterjee M et al (2021) Pasotuxizumab, a Bite\u00ae immune therapy for castration-resistant prostate cancer: phase I. Dose-Escalation Stud Findings Immunother 13(2):125\u2013141. https:\/\/doi.org\/10.2217\/imt-2020-0256","journal-title":"Dose-Escalation Stud Findings Immunother"},{"issue":"22","key":"1614_CR14","doi-asserted-by":"publisher","first-page":"2063","DOI":"10.1056\/NEJMoa2307980","volume":"389","author":"MJ Ahn","year":"2023","unstructured":"Ahn MJ, Cho BC, Felip E, Korantzis I, Ohashi K, Majem M et al (2023) Tarlatamab for patients with previously treated small-cell lung cancer. N Engl J Med 389(22):2063\u20132075. https:\/\/doi.org\/10.1056\/NEJMoa2307980","journal-title":"N Engl J Med"},{"key":"1614_CR15","unstructured":"(2023) FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer"},{"key":"1614_CR16","doi-asserted-by":"publisher","first-page":"104008","DOI":"10.1016\/j.cellimm.2019.104008","volume":"347","author":"J-Y Wang","year":"2020","unstructured":"Wang J-Y, Wang W-P (2020) B7\u2013H4, a promising target for immunotherapy. Cell Immunol 347:104008. https:\/\/doi.org\/10.1016\/j.cellimm.2019.104008","journal-title":"Cell Immunol"},{"issue":"3","key":"1614_CR17","doi-asserted-by":"publisher","first-page":"1570","DOI":"10.1158\/0008-5472.Can-04-3550","volume":"66","author":"I Simon","year":"2006","unstructured":"Simon I, Zhuo S, Corral L, Diamandis EP, Sarno MJ, Wolfert RL et al (2006) B7\u2013H4 is a novel membrane-bound protein and a candidate serum and tissue biomarker for ovarian cancer. Can Res 66(3):1570\u20131575. https:\/\/doi.org\/10.1158\/0008-5472.Can-04-3550","journal-title":"Can Res"},{"issue":"5","key":"1614_CR18","doi-asserted-by":"publisher","first-page":"1842","DOI":"10.1158\/1078-0432.Ccr-04-1658","volume":"11","author":"B Tringler","year":"2005","unstructured":"Tringler B, Zhuo S, Pilkington G, Torkko KC, Singh M, Lucia MS et al (2005) B7\u2013H4 is highly expressed in ductal and lobular breast cancer. Clin Cancer Res 11(5):1842\u20131848. https:\/\/doi.org\/10.1158\/1078-0432.Ccr-04-1658","journal-title":"Clin Cancer Res"},{"issue":"1","key":"1614_CR19","doi-asserted-by":"publisher","first-page":"44","DOI":"10.1016\/j.ygyno.2005.08.060","volume":"100","author":"B Tringler","year":"2006","unstructured":"Tringler B, Liu W, Corral L, Torkko KC, Enomoto T, Davidson S et al (2006) B7\u2013H4 overexpression in ovarian tumors. Gynecol Oncol 100(1):44\u201352. https:\/\/doi.org\/10.1016\/j.ygyno.2005.08.060","journal-title":"Gynecol Oncol"},{"issue":"1","key":"1614_CR20","doi-asserted-by":"publisher","first-page":"128","DOI":"10.1016\/j.yexcr.2005.01.018","volume":"306","author":"S Salceda","year":"2005","unstructured":"Salceda S, Tang T, Kmet M, Munteanu A, Ghosh M, Macina R et al (2005) The immunomodulatory protein B7\u2013H4 is overexpressed in breast and ovarian cancers and promotes epithelial cell transformation. Exp Cell Res 306(1):128\u2013141. https:\/\/doi.org\/10.1016\/j.yexcr.2005.01.018","journal-title":"Exp Cell Res"},{"key":"1614_CR21","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1016\/j.humpath.2016.06.011","volume":"57","author":"L Liang","year":"2016","unstructured":"Liang L, Jiang Y, Chen J-S, Niu N, Piao J, Ning J et al (2016) B7\u2013H4 expression in ovarian serous carcinoma: a study of 306 cases. Hum Pathol 57:1\u20136. https:\/\/doi.org\/10.1016\/j.humpath.2016.06.011","journal-title":"Hum Pathol"},{"issue":"2","key":"1614_CR22","doi-asserted-by":"publisher","first-page":"334","DOI":"10.1016\/j.ygyno.2007.03.035","volume":"106","author":"I Simon","year":"2007","unstructured":"Simon I, Katsaros D, Rigault de la Longrais I, Massobrio M, Scorilas A, Kim NW et al (2007) B7\u2013H4 is over-expressed in early-stage ovarian cancer and is independent of CA125 expression. Gynecologic Oncol 106(2):334\u201341. https:\/\/doi.org\/10.1016\/j.ygyno.2007.03.035","journal-title":"Gynecologic Oncol"},{"issue":"1","key":"1614_CR23","doi-asserted-by":"publisher","first-page":"119","DOI":"10.1016\/j.ygyno.2007.03.039","volume":"106","author":"T Miyatake","year":"2007","unstructured":"Miyatake T, Tringler B, Liu W, Liu S-H, Papkoff J, Enomoto T et al (2007) B7\u2013H4 (DD-O110) is overexpressed in high risk uterine endometrioid adenocarcinomas and inversely correlated with tumor T-cell infiltration. Gynecol Oncol 106(1):119\u2013127. https:\/\/doi.org\/10.1016\/j.ygyno.2007.03.039","journal-title":"Gynecol Oncol"},{"issue":"9","key":"1614_CR24","doi-asserted-by":"publisher","first-page":"2925","DOI":"10.1158\/1078-0432.Ccr-17-3123","volume":"25","author":"A Iizuka","year":"2019","unstructured":"Iizuka A, Nonomura C, Ashizawa T, Kondou R, Ohshima K, Sugino T et al (2019) A T-cell\u2013engaging B7\u2013H4\/CD3-bispecific Fab-scFv antibody targets human breast cancer. Clin Cancer Res 25(9):2925\u20132934. https:\/\/doi.org\/10.1158\/1078-0432.Ccr-17-3123","journal-title":"Clin Cancer Res"},{"issue":"Suppl 1","key":"1614_CR25","doi-asserted-by":"publisher","first-page":"A1291","DOI":"10.1136\/jitc-2023-SITC2023.1171","volume":"11","author":"E Ioffe","year":"2023","unstructured":"Ioffe E, Mehta NK, Meetze KA, Shapiro IM, Dobrowolska H, Huang B et al (2023) 1171CLN-418, a clinical-stage B7H4 x 4\u20131BB bispecific antibody with potential to treat patients with a wide range of solid tumors. J ImmunoTher Cancer 11(Suppl 1):A1291-A. https:\/\/doi.org\/10.1136\/jitc-2023-SITC2023.1171","journal-title":"J ImmunoTher Cancer"},{"issue":"7","key":"1614_CR26","doi-asserted-by":"publisher","first-page":"976","DOI":"10.1158\/1535-7163.Mct-24-0379","volume":"24","author":"K Abayasiriwardana","year":"2025","unstructured":"Abayasiriwardana K, Wu L, Laklai H, Nocula-Lugowska M, Tchistiakova L, Narula J et al (2025) A novel B7\u2013H4xCD3 bispecific T-cell engager (PF-07260437) synergizes with breast cancer standard of care and immune checkpoint therapies. Mol Cancer Ther 24(7):976\u2013992. https:\/\/doi.org\/10.1158\/1535-7163.Mct-24-0379","journal-title":"Mol Cancer Ther"},{"issue":"4","key":"1614_CR27","doi-asserted-by":"publisher","first-page":"625","DOI":"10.1016\/j.bbmt.2018.12.758","volume":"25","author":"DW Lee","year":"2019","unstructured":"Lee DW, Santomasso BD, Locke FL, Ghobadi A, Turtle CJ, Brudno JN et al (2019) ASTCT consensus grading for cytokine release syndrome and neurologic toxicity associated with immune effector cells. Biol Blood Marrow Transplant 25(4):625\u2013638. https:\/\/doi.org\/10.1016\/j.bbmt.2018.12.758","journal-title":"Biol Blood Marrow Transplant"},{"issue":"6","key":"1614_CR28","doi-asserted-by":"publisher","first-page":"495","DOI":"10.1056\/NEJMoa2203478","volume":"387","author":"P Moreau","year":"2022","unstructured":"Moreau P, Garfall AL, Donk NWCJVD, Nahi H, San-Miguel JF, Oriol A et al (2022) Teclistamab in relapsed or refractory multiple myeloma. New England J Med 387(6):495\u2013505. https:\/\/doi.org\/10.1056\/NEJMoa2203478","journal-title":"New England J Med"},{"key":"1614_CR29","unstructured":"Teclistamab Prescribing Information USPI. https:\/\/www.jnjlabels.com\/package-insert\/product-monograph\/prescribing-information\/TECVAYLI-pi.pdf. Accessed 25 March 2026"},{"issue":"9","key":"1614_CR30","doi-asserted-by":"publisher","first-page":"836","DOI":"10.1056\/NEJMoa1609783","volume":"376","author":"H Kantarjian","year":"2017","unstructured":"Kantarjian H, Stein A, G\u00f6kbuget N, Fielding AK, Schuh AC, Ribera JM et al (2017) Blinatumomab versus chemotherapy for advanced acute lymphoblastic leukemia. N Engl J Med 376(9):836\u2013847. https:\/\/doi.org\/10.1056\/NEJMoa1609783","journal-title":"N Engl J Med"},{"issue":"1","key":"1614_CR31","doi-asserted-by":"publisher","first-page":"57","DOI":"10.1016\/s1470-2045(14)71170-2","volume":"16","author":"MS Topp","year":"2015","unstructured":"Topp MS, G\u00f6kbuget N, Stein AS, Zugmaier G, O\u2019Brien S, Bargou RC et al (2015) Safety and activity of blinatumomab for adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 study. Lancet Oncol 16(1):57\u201366. https:\/\/doi.org\/10.1016\/s1470-2045(14)71170-2","journal-title":"Lancet Oncol"},{"issue":"6","key":"1614_CR32","doi-asserted-by":"publisher","first-page":"849","DOI":"10.1016\/s1074-7613(03)00152-3","volume":"18","author":"GL Sica","year":"2003","unstructured":"Sica GL, Choi IH, Zhu G, Tamada K, Wang SD, Tamura H et al (2003) B7\u2013H4, a molecule of the B7 family, negatively regulates T cell immunity. Immunity 18(6):849\u2013861. https:\/\/doi.org\/10.1016\/s1074-7613(03)00152-3","journal-title":"Immunity"},{"issue":"15","key":"1614_CR33","doi-asserted-by":"publisher","first-page":"4820","DOI":"10.1158\/0008-5472.Can-12-3457","volume":"73","author":"D Dangaj","year":"2013","unstructured":"Dangaj D, Lanitis E, Zhao A, Joshi S, Cheng Y, Sandaltzopoulos R et al (2013) Novel recombinant human b7\u2013h4 antibodies overcome tumoral immune escape to potentiate T-cell antitumor responses. Cancer Res 73(15):4820\u20134829. https:\/\/doi.org\/10.1158\/0008-5472.Can-12-3457","journal-title":"Cancer Res"},{"issue":"7","key":"1614_CR34","doi-asserted-by":"publisher","first-page":"295","DOI":"10.1186\/2047-783x-16-7-295","volume":"16","author":"Y Qian","year":"2011","unstructured":"Qian Y, Shen L, Xu C, Wu Z, Brockmeyer NH, Altmeyer P et al (2011) Development of a novel monoclonal antibody to B7\u2013H4: characterization and biological activity. Eur J Med Res 16(7):295\u2013302. https:\/\/doi.org\/10.1186\/2047-783x-16-7-295","journal-title":"Eur J Med Res"},{"key":"1614_CR35","doi-asserted-by":"publisher","first-page":"111913","DOI":"10.1016\/j.biopha.2021.111913","volume":"141","author":"G Miao","year":"2021","unstructured":"Miao G, Sun X (2021) Development of a novel anti-B7-H4 antibody enhances anti-tumor immune response of human T cells. Biomed Pharmacother 141:111913. https:\/\/doi.org\/10.1016\/j.biopha.2021.111913","journal-title":"Biomed Pharmacother"},{"issue":"Suppl 2","key":"1614_CR36","doi-asserted-by":"publisher","first-page":"A781","DOI":"10.1136\/jitc-2022-SITC2022.0748","volume":"10","author":"H Myint","year":"2022","unstructured":"Myint H, Shah S, Gutierrez M, Zsiros E, Nelson M, Zeidan S et al (2022) J ImmunoTher Cancer 10(Suppl 2):A781-A. https:\/\/doi.org\/10.1136\/jitc-2022-SITC2022.0748","journal-title":"J ImmunoTher Cancer"},{"issue":"15_suppl","key":"1614_CR37","doi-asserted-by":"publisher","first-page":"2529","DOI":"10.1200\/JCO.2019.37.15_suppl.2529","volume":"37","author":"JC Sachdev","year":"2019","unstructured":"Sachdev JC, Bauer TM, Chawla SP, Pant S, Patnaik A, Wainberg ZA et al (2019) Phase 1a\/1b study of first-in-class B7-H4 antibody, FPA150, as monotherapy in patients with advanced solid tumors. J Clin Oncol 37(15_suppl):2529. https:\/\/doi.org\/10.1200\/JCO.2019.37.15_suppl.2529","journal-title":"J Clin Oncol"},{"key":"1614_CR38","doi-asserted-by":"publisher","DOI":"10.3390\/cancers15102824","author":"M Shanshal","year":"2023","unstructured":"Shanshal M, Caimi PF, Adjei AA, Ma WW (2023) T-cell engagers in solid cancers-current landscape and future directions. Cancers (Basel). https:\/\/doi.org\/10.3390\/cancers15102824","journal-title":"Cancers (Basel)"},{"key":"1614_CR39","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2024.1426050","author":"L Zhou","year":"2024","unstructured":"Zhou L, Duan Y, Fu K, Zhang M, Li K, Yin R (2024) The role of B7-H4 in ovarian cancer immunotherapy: current status, challenges, and perspectives. Front Immunol. https:\/\/doi.org\/10.3389\/fimmu.2024.1426050","journal-title":"Front Immunol"},{"key":"1614_CR40","doi-asserted-by":"publisher","DOI":"10.1093\/immadv\/ltae005","author":"L Dewaele","year":"2025","unstructured":"Dewaele L, Fernandes RA (2025) Bispecific T-cell engagers for the recruitment of T cells in solid tumors: a literature review. Immunother Adv. https:\/\/doi.org\/10.1093\/immadv\/ltae005","journal-title":"Immunother Adv"},{"key":"1614_CR41","doi-asserted-by":"publisher","DOI":"10.3390\/cancers13020287","author":"J Middelburg","year":"2021","unstructured":"Middelburg J, Kemper K, Engelberts P, Labrijn AF, Schuurman J, van Hall T (2021) Overcoming challenges for CD3-bispecific antibody therapy in solid tumors. Cancers (Basel). https:\/\/doi.org\/10.3390\/cancers13020287","journal-title":"Cancers (Basel)"},{"issue":"1","key":"1614_CR42","doi-asserted-by":"publisher","first-page":"93","DOI":"10.1038\/s41392-022-00947-7","volume":"7","author":"Z Fu","year":"2022","unstructured":"Fu Z, Li S, Han S, Shi C, Zhang Y (2022) Antibody drug conjugate: the \u201cbiological missile\u201d for targeted cancer therapy. Signal Transduct Target Ther 7(1):93. https:\/\/doi.org\/10.1038\/s41392-022-00947-7","journal-title":"Signal Transduct Target Ther"},{"issue":"12_Supplement","key":"1614_CR43","doi-asserted-by":"publisher","DOI":"10.1158\/1538-7445.Am2022-1756","volume":"82","author":"SD Collins","year":"2022","unstructured":"Collins SD, Shaw PS, Fessler SP, Wang J, Mosher R (2022) Abstract 1756: Antitumor effect of XMT1660, a B7H4 targeting antibody drug conjugate, in an unselected panel of patient derived xenograft models of breast cancer. Cancer Res 82(12_Supplement):1756-. https:\/\/doi.org\/10.1158\/1538-7445.Am2022-1756","journal-title":"Cancer Res"},{"key":"1614_CR44","doi-asserted-by":"publisher","first-page":"S336","DOI":"10.1016\/j.annonc.2023.09.558","volume":"34","author":"J Wu","year":"2023","unstructured":"Wu J, Zhang J, Li H, Wang X, Zhang QY, Shi Y et al (2023) 381O First-in-human\/phase I trial of HS-20089, a B7\u2013H4 ADC, in patients with advanced solid tumors. Ann Oncol 34:S336. https:\/\/doi.org\/10.1016\/j.annonc.2023.09.558","journal-title":"Ann Oncol"},{"key":"1614_CR45","doi-asserted-by":"publisher","first-page":"S485","DOI":"10.1016\/j.annonc.2024.08.673","volume":"35","author":"F Meric-Bernstam","year":"2024","unstructured":"Meric-Bernstam F, Naito Y, Gaillard S, Shimoi T, Chung V, Davis AA et al (2024) 606O Initial results from a first-in-human study of the B7\u2013H4-directed antibody-drug conjugate (ADC) AZD8205 (puxitatug samrotecan) in patients with advanced\/metastatic solid tumors. Ann Oncol 35:S485\u2013S486. https:\/\/doi.org\/10.1016\/j.annonc.2024.08.673","journal-title":"Ann Oncol"},{"issue":"1","key":"1614_CR46","doi-asserted-by":"publisher","first-page":"48","DOI":"10.1038\/s41467-023-44308-6","volume":"15","author":"J Middelburg","year":"2024","unstructured":"Middelburg J, Sluijter M, Schaap G, G\u00f6yn\u00fck B, Lloyd K, Ovcinnikovs V et al (2024) T-cell stimulating vaccines empower CD3 bispecific antibody therapy in solid tumors. Nat Commun 15(1):48. https:\/\/doi.org\/10.1038\/s41467-023-44308-6","journal-title":"Nat Commun"}],"container-title":["Investigational New Drugs"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10637-026-01614-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10637-026-01614-2","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10637-026-01614-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T12:07:54Z","timestamp":1787054874000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10637-026-01614-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,22]]},"references-count":46,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2026,8]]}},"alternative-id":["1614"],"URL":"https:\/\/doi.org\/10.1007\/s10637-026-01614-2","relation":{},"ISSN":["0167-6997","1573-0646"],"issn-type":[{"value":"0167-6997","type":"print"},{"value":"1573-0646","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,22]]},"assertion":[{"value":"2 February 2026","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"19 April 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"22 May 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"All procedures were carried out in compliance with relevant laws and institutional guidelines and were approved by WCG IRB (IRB tracking number 20213510). This study was conducted in accordance with the Declaration of Helsinki and the guidelines of Good Clinical Practice. Written informed consent was obtained from all study patients before enrolment into the study.","order":1,"name":"Ethics","label":"Ethical approval and consent to participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":2,"name":"Ethics","label":"Patient consent for publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"DS is an employee and shareholder of Texas Oncology, shareholder of NEXT Oncology and reports honoraria from Syneos, consulting fees from Guidepoint, advisory board payments from Revolution Medicines and Nimbus Therapeutics, and ongoing or past institutional research funding for studies from Abbvie, Acrivon Therapeutics, ADC Therapeutics, Aprea Therapeutics, Ascentage Pharma Group, Astellas, Biomea Fusion, Boehringer Ingelheim, BJ Bioscience, BioNTech, Bristol-Myers Squibb, Compugen, Day One Biopharma, Dicerna\/Novo Nordisk, Exelixis, Fate Therapeutics, Gilead Sciences, GlaskoSmithKline, Haihe Pharmaceutical, Iconovir Bio, Immuneering, Impact Therapeutics, Incendia, Kura Oncology, MediLink Therapeutics, Mirati Therapeutics, ModeX Therapeutics, Monopteros Therapeutics, Navire Pharma Inc, Nimbus Therapeutics, NGM Biopharmaceuticals, OBI Pharma, OncoResponse Inc, Pfizer, Revolution Medicines, Step Pharmaceuticals, Symphogen, Tachyon Therapeutics, Teon Therapeutics, Tyligand Bioscience, Vincerx Pharma, Vividion Therapeutics, ZielBio Inc, Zymeworks Inc. HS reports institutional research funding from Amgen; consulting fees from AstraZeneca, Celgene, Eisai, Novartis, PUMA, Seattle Genetics, Sanofi and Sermonix; advisory board roles with AstraZeneca, Eisai, Eli Lilly, Novartis and PUMA; speaker fees from Merck; and licensing fees for intellectual property from Celyad Oncology. JS reports institutional research funding from Merck, AstraZenca, OnKure, A2 Biotherapeutics, RayzeBio, Lyell Immunopharma, Carisma, Seagen, Pfizer, Genentech, Abbvie, Xencor, and Celcuity; advisory board roles with GE Heathcare, Lyell Immunopharma, and Boehringer Ingelheim. AJF, SJ, SYT and CLC are employees of and own stock in Pfizer Inc. ML receives patent royalties from the Johns Hopkins University, is employed at Pfizer; and owns stock and other ownership interests of Pfizer.  FY reports honoraria from Gilead, AstraZeneca, Daichi Sankyo, Eli Lilly, Stemline, and ongoing or past institutional research funding for studies from Gilead Sciences, Pfizer, Genentech, Agendia, Merck. MCC reports research contracts with pharmaceutical companies to conduct clinical research including: Abbvie,  Pfizer, Genentech, Astra Zeneca, Merck, BMS, Natera, Delfi, Biodexa, Janssen, Incyte, Astellas. JL and EWW have no competing interests.","order":3,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Declarations"}}]}}