{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T17:33:12Z","timestamp":1790530392741,"version":"4.1.0"},"reference-count":21,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2026,1,6]],"date-time":"2026-01-06T00:00:00Z","timestamp":1767657600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,1,6]],"date-time":"2026-01-06T00:00:00Z","timestamp":1767657600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100004331","name":"Johnson and Johnson","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004331","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Cancer Chemother Pharmacol"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Prostate-specific membrane antigen (PSMA) has been identified as a therapeutic target for metastatic castration-resistant prostate cancer (mCRPC). The recent success of radioligands targeting PSMA spurred development of new PSMA-targeting agents including immunotherapy. JNJ-80038114 is a bispecific antibody that binds PSMA on tumor cells and CD3 on T cells to induce anti-tumor activity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This was a phase 1, open-label, multicenter study of JNJ-80038114 in participants with mCRPC and \u2265\u20091 prior systemic therapy. JNJ-80038114 was administered subcutaneously every 3 weeks (Q3W), starting at 0.1\u00a0mg. The primary endpoint was safety. Secondary endpoints included pharmacokinetics (PK), immunogenicity, and prostate-specific antigen (PSA).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      At final analysis, 39 participants received 0.1\u2013180\u00a0mg JNJ-80038114 across 11 dose-escalation cohorts for a median of 9.3 weeks (range, 0.1\u201331.1). The most common treatment-related adverse events (TRAEs; \u226520%) included cytokine release syndrome (CRS, 51.3%, all Grade 1\u20132), injection-site reactions (46.2%), and fatigue (30.8%). Related Grade\u2009\u2265\u20093 TRAEs occurred in 51.3% of participants; dose-limiting toxicities occurred in 3 (7.7%). Four participants (10.3%) developed clinically significant neuropathies. In 37 PK-evaluable participants, mean exposure (C\n                      <jats:sub>max<\/jats:sub>\n                      , AUC) increased with increasing doses. Anti-drug antibodies (ADA) were reported in 56.8% (21\/37) participants. One participant had confirmed PSA decrease\u2009\u2265\u200950%. Three participants had radiological responses in the context of rapidly rising PSA. Following a review of data, the study was terminated.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This first-in-human study of JNJ-80038114 was discontinued early due to its lack of preliminary clinical activity, neurologic toxicities, high rates of CRS, and the development of ADAs impacting PK.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinicaltrial.Gov information<\/jats:title>\n                    <jats:p>NCT05441501, Registered July 1, 2022.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00280-025-04846-w","type":"journal-article","created":{"date-parts":[[2026,1,6]],"date-time":"2026-01-06T14:27:12Z","timestamp":1767709632000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["A phase 1, first-in-human, dose escalation study of JNJ-80038114, a PSMAxCD3 bispecific antibody, in participants with metastatic castration-resistant prostate cancer"],"prefix":"10.1007","volume":"96","author":[{"given":"Andrew","family":"Hudson","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anuradha","family":"Jayaram","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin","family":"Garmezy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicholas A.","family":"Zorko","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin K.","family":"Zarrabi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ligi","family":"Mathews","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brent","family":"Rupnow","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mengjie","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Debopriya","family":"Ghosh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen","family":"Urtishak","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Francis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sherry C.","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward","family":"Attiyeh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johann","family":"de Bono","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,1,6]]},"reference":[{"issue":"6","key":"4846_CR1","doi-asserted-by":"publisher","first-page":"449","DOI":"10.1097\/PAI.0000000000000110","volume":"23","author":"MC Tsourlakis","year":"2015","unstructured":"Tsourlakis MC, Klein F, Kluth M, Quaas A, Graefen M, Haese A, Simon R, Sauter G, Schlomm T, Minner S (2015) PSMA expression is highly homogenous in primary prostate cancer. 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All authors had full access to the study data and approved the final version of the manuscript. Andrew Hudson: Honoraria and travel\/accommodation support from J&J. Anuradha Jayaram: no COI to declare. Benjamin Garmezy: funding and\/or consulting (all paid to his institution) for AbbVie, Accutar Biotechnology, Adcentrx Therapeutics, Arcus Biosciences, Arvinas, AstraZeneca, AVEO Oncology, CRISPR Therapeutics, Eikon Therapeutics, Exelixis, Roche\/Genentech, Flare Therapeutics, Halda Therapeutics, Harbor BioMed, HiberCell, IDEAYA Biosciences, Janssen, Janux Therapeutics, Jubilant Therapeutics, Kineta, Kinnate BioPharma, Loxo, Merck, Mink Therapeutics, Nuvation Bio, Profound Bio, Takeda Therapeutics, Xencor, Zenshine, Adaptimmune, Adicet Therapeutics, AIQ Global, Amgen, Bayer, Bicycle Therapeutics, Eisai, EMD Serono, Merck, Novartis, Pfizer, Rondo Therapeutics, Sanofi-Aventis, Seagen. Nicholas A Zorko: Consulting: Bayer (Institutional payment, personal fees), Takeda (Institutional, pro bono consulting), Telix-(travel expenses), GT Biopharma (FDAGTB-5550 IND sponsor and PI), Mosaic Research (consulting), Slingshot (consulting), Mosaic. Insights (consulting). Kevin K Zarrabi: reports receiving grants from Amgen (INST), IDEAYA (INST), Johnson & Johnson\/Janssen (INST), and 858 Therapeutics (INST); consulting fees from Pfizer; and payments or honoraria from OncLive and Association of Community Cancer Centers (ACCC). Ligi Mathews, Brent Rupnow, Mengjie Li, Debopriya Ghosh, Karen Urtishak, Peter Francis, Sherry Wang, Edward Attiyeh: employees and stockholders of Johnson & Johnson. Johann de Bono: Grants from Amgen, Astellas, AstraZeneca, AAA, Bayer, Bioxcel Therapeutics, Crescendo, Daiichi-Sankyo, Endocyte, Genentech\/Roche, GSK, ImCheck Therapeutics, Janssen, Merck Serono, Merck Sharp & Dohme, Novartis, Oncternal, Pfizer, and Sanofi Aventis; consulting fees from AstraZeneca, Astellas, Bayer, Cellcentric, Daiichi, Genentech\/Roche, Pfizer, GSK, Janssen, Merck Serono, MSD, Menarini\/Silicon Biosystems, Orion, Sanofi Aventis, Sierra Oncology, Taiho, Pfizer, and Vertex; honoraria from AstraZeneca, Astellas, Bayer, Cellcentric, Daiichi, Genentech, Genmab, GSK, Janssen, Merck Sereno, Mycrix, MSD, Orion Sanofi Aventis, Taiho, Crescendo, and Pfizer; payment for testimony from Amgen, Astellas, AstraZeneca, Bayer, Bioxcel Therapeutics, Boehringer Ingelheim, Cellcentric, Daiichi, Eisai, Genmab, GSK, Harpoon, ImCheck Therapeutics, Janssen, Merck Serono, Merck Sharp\/Dohme, Menarini\/Silicon Biosystems, Orion, Pfizer, Qiagen, Sanofi Aventis, Sierra Oncology, Taiho, Terumo, Vertex Pharmaceuticals, and Genentech\/Roche; and travel support from Amgen, Astellas, AstraZeneca, Bayer, Bioxcel Therapeutics, Boehringer Ingelheim, Cellcentric, Daiichi, Eisai, Genmab, GSK, Harpoon, ImCheck Therapeutics, Janssen, Merck Serono, MSD, Menarini\/Silicon Biosystems, Orion, Pfizer, Qiagen, Sanofi Aventis, Sierra Oncology, Taiho, Terumo, Vertex Pharmaceuticals, and Genentech\/Roche.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"5"}}