Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies

Seagen

Status and phase: Completed; Phase 1

Conditions: Lymphoma, Large-Cell, Anaplastic; Disease, Hodgkin; Lymphoma, Non-Hodgkin

Treatments: Drug: SGN-35

Study type: Interventional

Funder types: Industry

Identifiers

NCT00430846

SG035-0001

Details and patient eligibility

About

Phase I study to define the safety profile and pharmacokinetic parameters of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies. This is a single-arm, open-label, Phase I dose escalation study designed to define the MTD, PK, immunogenicity and anti-tumor activity of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must have histologically confirmed CD30-positive hematologic malignancy.
• Patients with HL must have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy after initial radiotherapy for early stage disease and were ineligible for, refused treatment by, or previously received stem cell transplant.
• Patients must have measurable disease of at least 10mm as documented by radiographic technique.
• Must be at least 18 years of age.

Exclusion criteria

• Patients with current diagnosis of pcALCL (systemic ALCL eligible).
• Patients with history of allogeneic stem cell transplant.
• Patients who have had previous treatment with any anti-CD30 antibody.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

A

Experimental group

Treatment:

Drug: SGN-35