A phase I/II study of rovalpituzumab tesirine in delta-like 3—expressing advanced solid tumors

Aaron S. Mansfield, David S. Hong, Christine L. Hann, Anna F. Farago, Himisha Beltran, Saiama N. Waqar, Andrew E. Hendifar, Lowell B. Anthony, Matthew H. Taylor, Alan H. Bryce, Scott T. Tagawa, Karl Lewis, Jiaxin Niu, Christine H. Chung, James M. Cleary, Michael Rossi, Carrianne Ludwig, Ricardo Valenzuela, Yan Luo, Rahul Aggarwal

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26 Scopus citations


Delta-like protein 3 (DLL3) is highly expressed in solid tumors, including neuroendocrine carcinomas/neuroendocrine tumors (NEC/NET). Rovalpituzumab tesirine (Rova-T) is a DLL3-targeting antibody-drug conjugate. Patients with NECs and other advanced DLL3-expressing tumors were enrolled in this phase I/II study (NCT02709889). The primary endpoint was safety. Two hundred patients were enrolled: 101 with NEC/NET (large-cell NEC, gastroenteropancreatic NEC, neuroendocrine prostate cancer, and other NEC/NET) and 99 with other solid tumors (melanoma, medullary thyroid cancer [MTC], glioblastoma, and other). The recommended phase II dose (RP2D) was 0.3 mg/kg every 6 weeks (q6w) for two cycles. At the RP2D, grade 3/4 adverse events included anemia (17%), thrombocytopenia (15%), and elevated aspartate aminotransferase (8%). Responses were confirmed in 15/145 patients (10%) treated at 0.3 mg/kg, including 9/69 patients (13%) with NEC/NET. Rova-T at 0.3 mg/kg q6w had manageable toxicity, with antitumor activity observed in patients with NEC/NET, melanoma, MTC, and glioblastoma.

Original languageEnglish
Article number74
Journalnpj Precision Oncology
Issue number1
StatePublished - Dec 2021


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