Clinical trial · Interventional
Safety and Pharmacokinetics of Escalating Doses of DNIB0600A in Participants With Non-Small Cell Lung Cancer (NSCLC) and Platinum Resistant Ovarian Cancer
A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DNIB0600A in Patients With Non-Small Cell Lung Cancer and Platinum-Resistant Ovarian Cancer
NCT01363947CI-TRIAL-00028007completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer, Ovarian Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DNIB0600A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation Cohort (DNIB0600A)
- description
- Participants will receive IV infusions of DNIB0600A at doses ranging from 0.2 milligrams/kilogram (mg/kg) to 2.8 mg/kg q3w until dose-limiting toxicity (DLT) is reached, or up to 28 cycles.
- interventionNames
- Drug: DNIB0600A
- type
- EXPERIMENTAL
- label
- Expansion Cohort (DNIB0600A)
- description
- Participants will receive 2.4 mg/kg, by IV infusion, of DNIB0600A q3w for up to 26 cycles.
- interventionNames
- Drug: DNIB0600A
Primary outcomes (1)
- measure
- Percentage of Participants With Adverse Events (AEs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.