Safety and Pharmacokinetics of Escalating Doses of DNIB0600A in Participants With Non-Small Cell Lung Cancer (NSCLC) and Platinum Resistant Ovarian Cancer
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jun 7, 2017 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Genentech, Inc.
- Interventions being studied
- Drug: DNIB0600A
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- HonorHealth Research Institute - Pima CenterScottsdale, Arizona
- Smilow Cancer Hospital at Yale New HavenNew Haven, Connecticut
- Sarah Cannon Research Inst.Nashville, Tennessee
- Univ of Texas SW Medical CtrDallas, Texas
- Hospital del Mar; Servicio de OncologiaBarcelona
- Hospital Univ Vall d'Hebron; Servicio de OncologiaBarcelona
- Hospital General Universitario Gregorio Marañon; Servicio de OncologiaMadrid
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 7, 2017. Always confirm current availability with the study team.