Clinical trial · Interventional
Study of MDX-1411 Given Every 14 Days With Pre-medications to Subjects With Clear Cell Kidney Cancer.
A Phase 1, Open-Label, Multicenter Dose-escalation, Multidose Study of MDX1411 Administered Every 14 Days in Subjects With Advanced or Recurrent Clear Cell Renal Cell Carcinoma
NCT00656734CI-TRIAL-00010282MDX1411-01completedPhase 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)
To determine the highest and safest tolerated dose of MDX-1411 for the treatment of clear cell renal cell carcinoma (Kidney cancer).
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 |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MDX 1411 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MDX 1411
- description
- Dose Escalation Cohorts
- interventionNames
- Biological: MDX 1411
Primary outcomes (2)
- measure
- Determine the safety profile of MDX 1411
- timeFrame
- duration of study
- measure
- Determine the maximum tolerated dose of MDX 1411
- timeFrame
- duration of study
Secondary outcomes (1)
- measure
- Determine the best overall response rate (BORR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of RCC with clear cell component * Measurable disease * Treated with up to 6 prior systemic therapies for advanced/recurrent disease or have become intolerant to a systemic therapy * Subjects with treated brain metastases must be without magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks and off steroids for at least 4 weeks to be eligible * At least 28 days since the last chemotherapy * At least 28 days before the first dose of MDX 1411 since any major surgery * ECOG performance status 0-2 * No known positivity for human immunodeficiency virus (HIV), Hep B or C Exclusion Criteria: * Previous treatment with any other anti-CD70 antibody * Active infection requiring i.v systemic therapy within 28 days before first dose * Evidence of bleeding diathesis or coagulopathy * Active autoimmune disease requiring immunosuppressive therapy * Known current drug or alcohol abuse * Any underlying medical condition which will make the administration of MDX 1411 hazardous * Psychiatric illness or social situation that would preclude study compliance
References
Publications (0)
Data not yet available
No reference posted for this study.