At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 58 enrolled
Drug / intervention
MEDI0639biological
Likely dose
Not stated in record
Key inclusion· 6
- ✓Histologically or cytologically confirmed solid tumors refractory to standard therapy or with no standard therapy available
- ✓Age ≥18 years
- ✓ECOG Performance Status 0 or 1
- ✓Left ventricular ejection fraction (LVEF) >50% by echocardiogram
Key exclusion· 12
- ✕Brain metastases present
- ✕Prior or concurrent treatment with DLL4 inhibitors
- ✕Concurrent investigational anticancer therapy (within 4 weeks for non-antibodies, 6 weeks for monoclonal antibodies)
- ✕Concurrent or previous concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal cancer therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI0639 in Adult Subjects With Advanced Solid Tumors
In Brief
A Phase 1 clinical trial evaluating MEDI0639 for Solid Tumors. Completed, enrolled 58 participants across 11 sites.
Detailed Summary
This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm, dose-escalation (3+3) study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI0639.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumors
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2012
First PostedApr 2012
Primary CompletionDec 2015
TodayJul 2026
First PostedApr 16, 2012
Enrollment StartApr 1, 2012
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 14.2 years ago
Interventions
MEDI0639biological
MEDI0639 is an immunoglobulin G1 lambda (IgG1λ) monoclonal antibody. MEDI0639 selectively binds to DLL4 and blocks its ability to bind to and activate signaling through the Notch receptors.