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

To establish the safety and tolerability profile of MDX-1401 in patients with relapsed or refractory Hodgkin's Lymphoma (HL).

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