A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies

• Status: Terminated
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will examine the safety profile of SGN-35 alone and in combination with gemcitabine. The study will test increasing doses of SGN-35 given weekly to small groups of patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.; Seattle Genetics, Inc.
• Treatments: Antibodies; Brentuximab Vedotin; Gemcitabine

Criteria

Inclusion Criteria:

• Histologically confirmed CD30-positive hematologic malignancy.

• Patients with HL must have failed systemic chemotherapy.

• Patients with other CD30-positive malignancies (including ALCL) must be beyond first remission or refractory to front line chemotherapy.

• Patients must have measurable disease of at least 1.5 cm as documented by radiographic technique.

Exclusion Criteria:

• Current diagnosis of primary cutaneous ALCL (systemic ALCL eligible).

• History of allogeneic stem cell transplant.

• Patients who have had previous treatment with any anti-CD30 antibody.