Ovarian Cancer Clinical Trial
Safety and Pharmacokinetics of Escalating Doses of DNIB0600A in Participants With Non-Small Cell Lung Cancer (NSCLC) and Platinum Resistant Ovarian Cancer
Summary
Study DNB4987g is a Phase I, multicenter, open label, dose-escalation study of DNIB0600A administered as a single agent by intravenous (IV) infusion every three weeks (q3w) to participants with non-squamous NSCLC or non-mucinous, platinum-resistant ovarian cancer. The study will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.
Eligibility Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologic documentation of incurable, locally advanced or metastatic disease that has failed prior chemotherapy and for which no standard therapy exists, including the following: non-squamous NSCLC or non-mucinous and platinum-resistant ovarian cancer
Availability and willingness to provide an adequate archival sample of tumor
Measurable disease
For fertile men or women of childbearing potential, documented willingness to use a highly effective means of contraception
Exclusion Criteria:
Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy within 4 weeks prior to study treatment
Major surgical procedure within 4 weeks prior to study treatment
Known active bacterial, viral, fungal, mycobacterial, or other infection (including human immunodeficiency virus [HIV] and atypical mycobacterial disease, but excluding fungal infections of the nail beds)
Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
Untreated or active central nervous system (CNS) metastases
Requirement for supplemental oxygen to carry out activities of daily living
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders; or a serious non-healing wound or fracture
For participants in the second NSCLC cohort expansion, not more than two prior regimens in the metastatic setting
Pregnancy or breast-feeding
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There are 7 Locations for this study
Scottsdale Arizona, 85258, United States
New Haven Connecticut, 06510, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75390, United States
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Madrid , 28007, Spain
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