Clinical trial · Interventional
Safety Study of MGA271 in Refractory Cancer
A Phase 1 Dose Escalation Study of MGA271 in Refractory Cancer
NCT01391143CI-TRIAL-00056408completedPhase 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)
The purpose of this study is to evaluate the safety of MGA271 when given by intravenous (IV) infusion to patients with refractory cancer. The study will also evaluate how long MGA271 stays in the blood and how long it takes for it to leave the body, what is the highest dose that can safely be given, and whether it may have an effect on tumors.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Triple-negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MGA271 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MGA271
- description
- Fc-optimized, humanized monoclonal antibody
- interventionNames
- Biological: MGA271
Primary outcomes (1)
- measure
- Safety
- timeFrame
- Study Day 50 or 28 days after last infusion
- description
- Adverse events, serious adverse events, ECG monitoring, adrenal function monitoring, monitoring for development of anti-drug antibodies
Secondary outcomes (1)
- measure
- Maximum tolerated dose
- timeFrame
- Study Day 50 or 28 days after last infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed carcinoma (prostate cancer, renal cell carcinoma, head and neck cancer, triple-negative breast cancer, bladder cancer, non-small cell lung cancer) or melanoma that overexpresses B7-H3. * Progressive disease during or after last treatment regimen. * Appropriate treatment history for histological entity. * ECOG Performance Status \<= 1. * Life expectancy \>= 3 months. * Measurable disease or evaluable disease with relevant tumor marker elevation. * Acceptable laboratory parameters and adequate organ reserve. Exclusion Criteria: * Major surgery or trauma within four weeks before enrollment. * Known hypersensitivity to murine or recombinant proteins, polysorbate 80, or any excipient contained in the drug formulation. * Grade 3 colitis, hepatitis, pneumonitis uveitis, myocarditis, myositis, CNS toxicity or autoimmune related neuromuscular toxicity such as myasthenia gravis associated with the administration of an immune checkpoint inhibitor * Second primary malignancy that has not been in remission for greater than 3 years. Treated non-melanoma skin cancer, cervical carcinoma in situ on biopsy, or squamous intraepithelial lesion on PAP smear, localized prostate cancer (Gleason score \< 6), or resected melanoma in situ are exceptions and do not require a 3 year remission. * Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within four weeks of enrollment. Patients requiring any oral antiviral, fungal, or bacterial therapy must have completed treatment within one week of enrollment. * Vaccination within 2 weeks of enrollment (except for annual flu vaccine). * History of chronic or recurrent infections that require continual use of antiviral, antifungal, or antibacterial agents.
References
Publications (0)
Data not yet available
No reference posted for this study.