{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T02:42:49Z","timestamp":1792636969375,"version":"4.5.0"},"reference-count":16,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"12","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2019,4,20]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>To evaluate the safety, pharmacokinetics, and pharmacodynamics of Hu5F9-G4 (5F9), a humanized IgG4 antibody that targets CD47 to enable phagocytosis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>PATIENTS AND METHODS<\/jats:title>\n                    <jats:p>Adult patients with solid tumors were treated in four cohorts: part A, to determine a priming dose; part B, to determine a weekly maintenance dose; part C, to study a loading dose in week 2; and a tumor biopsy cohort.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>Sixty-two patients were treated: 11 in part A, 14 in B, 22 in C, and 15 in the biopsy cohort. Part A used doses that ranged from 0.1 to 3 mg\/kg. On the basis of tolerability and receptor occupancy studies that showed 100% CD47 saturation on RBCs, 1 mg\/kg was selected as the priming dose. In subsequent groups, patients were treated with maintenance doses that ranged from 3 to 45 mg\/kg, and most toxicities were mild to moderate. These included transient anemia (57% of patients), hemagglutination on peripheral blood smear (36%), fatigue (64%), headaches (50%), fever (45%), chills (45%), hyperbilirubinemia (34%), lymphopenia (34%), infusion-related reactions (34%), and arthralgias (18%). No maximum tolerated dose was reached with maintenance doses up to 45 mg\/kg. At doses of 10 mg\/kg or more, the CD47 antigen sink was saturated by 5F9, and a 5F9 half-life of approximately 13 days was observed. Strong antibody staining of tumor tissue was observed in a patient at 30 mg\/kg. Two patients with ovarian\/fallopian tube cancers had partial remissions for 5.2 and 9.2 months.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>5F9 is well tolerated using a priming dose at 1 mg\/kg on day 1 followed by maintenance doses of up to 45 mg\/kg weekly.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco.18.02018","type":"journal-article","created":{"date-parts":[[2019,2,27]],"date-time":"2019-02-27T15:57:26Z","timestamp":1551283046000},"page":"946-953","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":562,"title":["First-in-Human, First-in-Class Phase I Trial of the Anti-CD47 Antibody Hu5F9-G4 in Patients With Advanced Cancers"],"prefix":"10.1200","volume":"37","author":[{"given":"Branimir I.","family":"Sikic","sequence":"first","affiliation":[{"name":"Stanford University School of Medicine, Stanford, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nehal","family":"Lakhani","sequence":"additional","affiliation":[{"name":"South Texas Accelerated Therapeutics Midwest, Grand Rapids, MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amita","family":"Patnaik","sequence":"additional","affiliation":[{"name":"South Texas Accelerated Therapeutics, San Antonio, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sumit A.","family":"Shah","sequence":"additional","affiliation":[{"name":"Stanford University School of Medicine, Stanford, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sreenivasa R.","family":"Chandana","sequence":"additional","affiliation":[{"name":"South Texas Accelerated Therapeutics Midwest, Grand Rapids, MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Drew","family":"Rasco","sequence":"additional","affiliation":[{"name":"South Texas Accelerated Therapeutics, San Antonio, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A. Dimitrios","family":"Colevas","sequence":"additional","affiliation":[{"name":"Stanford University School of Medicine, Stanford, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy","family":"O\u2019Rourke","sequence":"additional","affiliation":[{"name":"South Texas Accelerated Therapeutics Midwest, Grand Rapids, MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sujata","family":"Narayanan","sequence":"additional","affiliation":[{"name":"Stanford University School of Medicine, Stanford, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyriakos","family":"Papadopoulos","sequence":"additional","affiliation":[{"name":"South Texas Accelerated Therapeutics, San Antonio, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George A.","family":"Fisher","sequence":"additional","affiliation":[{"name":"Stanford University School of Medicine, Stanford, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victor","family":"Villalobos","sequence":"additional","affiliation":[{"name":"University of Colorado Cancer Center, Aurora, CO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan S.","family":"Prohaska","sequence":"additional","affiliation":[{"name":"Stanford University School of Medicine, Stanford, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maureen","family":"Howard","sequence":"additional","affiliation":[{"name":"Stanford University School of Medicine, Stanford, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muralidhar","family":"Beeram","sequence":"additional","affiliation":[{"name":"South Texas Accelerated Therapeutics, San Antonio, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark P.","family":"Chao","sequence":"additional","affiliation":[{"name":"Forty Seven, Menlo Park, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Balaji","family":"Agoram","sequence":"additional","affiliation":[{"name":"Forty Seven, Menlo Park, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James Y.","family":"Chen","sequence":"additional","affiliation":[{"name":"Forty Seven, Menlo Park, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie","family":"Huang","sequence":"additional","affiliation":[{"name":"Forty Seven, Menlo Park, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew","family":"Axt","sequence":"additional","affiliation":[{"name":"Forty Seven, Menlo Park, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie","family":"Liu","sequence":"additional","affiliation":[{"name":"Forty Seven, Menlo Park, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jens-Peter","family":"Volkmer","sequence":"additional","affiliation":[{"name":"Forty Seven, Menlo Park, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ravindra","family":"Majeti","sequence":"additional","affiliation":[{"name":"Stanford University School of Medicine, Stanford, CA"},{"name":"Forty Seven, Menlo Park, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irving L.","family":"Weissman","sequence":"additional","affiliation":[{"name":"Stanford University School of Medicine, Stanford, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chris H.","family":"Takimoto","sequence":"additional","affiliation":[{"name":"Forty Seven, Menlo Park, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dana","family":"Supan","sequence":"additional","affiliation":[{"name":"Stanford University School of Medicine, Stanford, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heather A.","family":"Wakelee","sequence":"additional","affiliation":[{"name":"Stanford University School of Medicine, Stanford, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rhonda","family":"Aoki","sequence":"additional","affiliation":[{"name":"Stanford University School of Medicine, Stanford, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark D.","family":"Pegram","sequence":"additional","affiliation":[{"name":"Stanford University School of Medicine, Stanford, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sukhmani K.","family":"Padda","sequence":"additional","affiliation":[{"name":"Stanford University School of Medicine, Stanford, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.1016\/S0962-8924(00)01906-1"},{"key":"B2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cell.2010.07.044"},{"key":"B3","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.1121623109"},{"key":"B5","doi-asserted-by":"publisher","DOI":"10.1016\/j.cell.2009.05.045"},{"key":"B6","doi-asserted-by":"publisher","DOI":"10.1016\/j.biopha.2015.05.017"},{"key":"B7","doi-asserted-by":"publisher","DOI":"10.1126\/scitranslmed.3001375"},{"key":"B8","doi-asserted-by":"publisher","DOI":"10.1126\/science.288.5473.2051"},{"key":"B9","doi-asserted-by":"crossref","first-page":"e0137345","DOI":"10.1371\/journal.pone.0137345","volume":"10","author":"Liu J","year":"2015","journal-title":"PLoS One"},{"key":"B10","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2008-03-143008"},{"key":"B11","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/89.15.1138"},{"key":"B12","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djp079"},{"key":"B13","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2008.10.026"},{"key":"B14","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2013.53.5229"},{"key":"B16","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2008.170"},{"key":"B18","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1807315"},{"key":"B19","first-page":"S65","volume":"42","author":"Buckeridge C","year":"2015","journal-title":"J Pharmacokinet Pharmacodyn"}],"container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO.18.02018","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,5,29]],"date-time":"2022-05-29T04:09:56Z","timestamp":1653797396000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.18.02018"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,4,20]]},"references-count":16,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2019,4,20]]}},"alternative-id":["10.1200\/JCO.18.02018"],"URL":"https:\/\/doi.org\/10.1200\/jco.18.02018","relation":{"has-review":[{"id-type":"doi","id":"10.3410\/f.735172097.793583613","asserted-by":"object"}]},"ISSN":["0732-183X","1527-7755"],"issn-type":[{"value":"0732-183X","type":"print"},{"value":"1527-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,4,20]]},"assertion":[{"value":"2019-02-27","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}