Clinical trial · Interventional
Phase 1 Study of MDX-1401 in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma
A Phase 1, Open-label, Dose-escalation, Multidose Study of MDX-1401 Administered Weekly for 4 Weeks in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma
NCT00634452CI-TRIAL-00008614MDX1401-01completedPhase 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 establish the safety and tolerability profile of MDX-1401 in patients with relapsed or refractory Hodgkin's Lymphoma (HL).
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 |
|---|---|---|---|
| Hodgkin's Lymphomas | Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MDX-1401 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MDX-1401
- description
- MDX-1401 iv at various doses
- interventionNames
- Biological: MDX-1401
Primary outcomes (1)
- measure
- Safety and Tolerability Profile
- timeFrame
- Two years
Secondary outcomes (2)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Day 50
- measure
- Tumor response assessment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of CD30-positive HL by immunohistochemistry or flow cytometry * Must have failed or relapsed following second line chemotherapy or radiation or failed/relapsed following autologous stem cell transplant * Bi-measurable disease * ECOG Performance Status of 0 - 2 * Meet all screening laboratory values Exclusion Criteria: * Previous treatment with any other anti-CD30 antibody * History of allogeneic transplant * Any tumor lesion greater than or equal to 10 cm in diameter * Any active or chronic significant infection * Underlying medical condition which will make the administration of MDX- 1401 hazardous * Concomitant corticosteroids, chemotherapy, investigational agents, other anti-HL biologics, or radiation therapy
References
Publications (0)
Data not yet available
No reference posted for this study.