{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,26]],"date-time":"2026-10-26T18:54:26Z","timestamp":1793040866040,"version":"4.5.0"},"reference-count":11,"publisher":"SAABRON PRESS","issue":"1","license":[{"start":{"date-parts":[[2023,1,19]],"date-time":"2023-01-19T00:00:00Z","timestamp":1674086400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,1,19]],"date-time":"2023-01-19T00:00:00Z","timestamp":1674086400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100004328","name":"Genentech","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004328","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Hematol Int"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>This phase 1 trial assessed the safety, pharmacokinetics, and preliminary antitumor activity of RO7297089, an anti-BCMA\/CD16a bispecific antibody.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>RO7297089 was administered weekly by intravenous infusion to patients with relapsed\/refractory multiple myeloma. The starting dose was 60\u00a0mg in this dose-escalation study utilizing a modified continual reassessment method with overdose control model.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Overall, 27 patients were treated at doses between 60 and 1850\u00a0mg. The maximally administered dose was 1850\u00a0mg due to excipients in the formulation that did not allow for higher doses to be used. The maximum tolerated dose was not reached. The most common adverse events irrespective of grade and relationship to the drug were anemia, infusion-related reaction, and thrombocytopenia. Most common treatment-related grade\u2009\u2265\u20093 toxicities were ALT\/AST increase and reduced lymphocyte count. Pharmacokinetic studies suggested non-linear pharmacokinetics and target-mediated drug disposition, with a trend of approaching linear pharmacokinetics at doses of 1080\u00a0mg and higher. Partial response was observed in two patients (7%), minimal response in two patients (7%), and stable disease in 14 patients (52%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>RO7297089 was well tolerated at doses up to 1850\u00a0mg, and the efficacy data supported activity of RO7297089 in multiple myeloma. Combination with other agents may further enhance its potential as an innate immune cell engager in multiple myeloma.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov: NCT04434469; Registered June 16, 2020;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT04434469\">https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT04434469<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s44228-022-00023-5","type":"journal-article","created":{"date-parts":[[2023,1,19]],"date-time":"2023-01-19T06:19:05Z","timestamp":1674109145000},"page":"43-51","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":26,"title":["Phase I Study of Safety and Pharmacokinetics of RO7297089, an Anti-BCMA\/CD16a Bispecific Antibody, in Patients with Relapsed, Refractory Multiple Myeloma"],"prefix":"10.46989","volume":"5","clinical-trial-number":[{"clinical-trial-number":"nct04434469","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2340-6068","authenticated-orcid":false,"given":"Torben","family":"Plesner","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon J.","family":"Harrison","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hang","family":"Quach","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cindy","family":"Lee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adam","family":"Bryant","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annette","family":"Vangsted","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jane","family":"Estell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michel","family":"Delforge","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fritz","family":"Offner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Twomey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Voleak","family":"Choeurng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junyi","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Hendricks","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shannon M.","family":"Ruppert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teiko","family":"Sumiyoshi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen","family":"Miller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eunpi","family":"Cho","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fredrik","family":"Schjesvold","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"26435","published-online":{"date-parts":[[2023,1,19]]},"reference":[{"issue":"4","key":"23_CR1","doi-asserted-by":"publisher","first-page":"360","DOI":"10.1016\/j.mayocp.2013.01.019","volume":"88","author":"JR Mikhael","year":"2013","unstructured":"Mikhael JR, Dingli D, Roy V, Reeder CB, Buadi FK, Hayman SR, Dispenzieri A, Fonseca R, Sher T, Kyle RA, Lin Y, Russell SJ, Kumar S, Bergsagel PL, Zeldenrust SR, Leung N, Drake MT, Kapoor P, Ansell SM, Witzig TE, Lust JA, Dalton RJ, Gertz MA, Stewart AK, Rajkumar SV, Chanan-Khan A, Lacy MQ, Mayo C. 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SH reports consultancy for Abbvie, Amgen, Celgene\/Juno\/BMS, Janssen Cilag, Novartis, Roche\/Genentech, Haemalogix, Sanofi; research funding from Abbvie, Amgen, Celgene\/Juno\/BMS, Janssen Cilag, Novartis, Roche\/Genentech, Haemalogix, Sanofi; honoraria from Abbvie, Amgen, Celgene\/Juno\/BMS, Janssen Cilag, Novartis, Roche\/Genentech, Haemalogix, Sanofi; speakers bureau for Abbvie, Amgen, Celgene\/Juno\/BMS, Janssen Cilag, Novartis, Roche\/Genentech; and advisory committee membership for Abbvie, Amgen, Celgene\/Juno\/BMS, Janssen Cilag, Novartis, Roche\/Genentech, Haemalogix, Sanofi. HQ reports advisory committee membership for Amgen, Antengene, BeiGene, Celgene\/ BMS, CSL Behring, Janssen Cilag, Karyopharm, Sanofi, Glaxo Smith Kline; research support from Amgen, Celgene\/ BMS, Sanofi, Antengene, Karyopharm, Glaxo Smith Kline; honoraria from Abbvie, Amgen, Antengene, BeiGene, Celgene\/ BMS, Janssen Cilag, Sanofi; and speakers bureau for Amgen, Abbvie, Antegenene, Celgene\/BMS, Glaxo Smith Kline. CL was an advisor for Amgen, Janssen, BMS, Takeda, Antengene; and received research support from BMS. AB received honoraria from Amgen, Sandoz, Pfizer, Roche. AV, JE, MD, FO have nothing to disclose. PT, VC, JL, RH, SMP, TS, KM, and EC are employees of Genentech, Inc. and shareholders of F. Hoffmann La Roche, Ltd. FS receieved honoraria from Amgen, Takeda, Sanofi; consulting\/advisory roles for Celgene, Janssen, Oncopeptides, Sanofi; and research funding from Celgene, Sanofi, Janssen, Oncopeptides, GSK.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"This study was conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki. Written informed consent was obtained from all patients prior to enrollment, in agreement with approved protocols from ethics committees at all study sites.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval and Consent to Participate"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for Publication"}}]}}