Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors

Inclusion Criteria

• •Histologically confirmed, unresectable advanced solid malignancy with documented disease progression after at least 1 prior systemic therapy
• •Disease is relapsed/refractory to prior standard systemic therapy or for which standard or curative therapy does not exist or is not considered appropriate by the Investigator.
• •Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• •Delta-like protein 3 (DLL3)-expressing malignancy based on central immunohistochemical (IHC) testing of representative baseline tumor tissue (archived tissue or on-study biopsy). Positive is defined as staining in ≥ 1% of tumor cells.
• •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• •Minimum life expectancy of at least 12 weeks
• •Subjects with a history of central nervous system (CNS) metastases must have documentation of stable or improved brain imaging for at least 2 weeks after completion of definitive treatment and within 2 weeks prior to first dose of Study Drug, off or on a stable dose of corticosteroids. Definitive treatment may include surgical resection, whole brain irradiation, and/or stereotactic radiation therapy. (Applicable to tumor types of non-CNS primary origin only)
• •Recovery to Grade 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration
• •Adequate hematologic and organ function as confirmed by laboratory values
• •Last dose of any prior therapy administered by the following time intervals before the first dose of study drug:
• •1. Chemotherapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies): 2 weeks.
• •2. Immune-checkpoint inhibitors (e.g., anti-programmed death protein 1 \[PD-1\], anti-programmed death-ligand 1 \[PD-L1\], or anti-cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\]), monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies: 4 weeks (2 weeks with documented disease progression).
• •Females of childbearing potential must have a negative beta human chorionic gonadotropin (β-hCG) pregnancy test result within 7 days prior to the first dose of study drug. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.