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

A Phase I Dose Escalation Study of SGN-35 in Patients With Relapsed/Refractory CD30-Positive Hematologic Malignancies.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00430846

Enrollment

Registered

2007-02-02

Start date

2006-11-30

Completion date

2009-07-31

Last updated

2014-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin

Keywords

Antigens,CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, Lymphoma, Non-Hodgkin, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Hematologic Diseases, Lymphoma

Brief summary

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.

Interventions

DRUGSGN-35

Every 21 days. Dose Escalating. 0.1 - 3.6 mg/kg

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events and laboratory abnormalities	1 month after last dose

Secondary

Measure	Time frame
PK profile	2 months after last dose
Immunogenicity (anti-SGN-35 antibodies)	1 month after last dose
Anti-tumor activity	1 month after last dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026