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

A Phase I Dose Escalation Study of Weekly SGN-35 Monotherapy and in Combination With Gemcitabine in Patients With Relapsed/Refractory CD30-positive Hematologic Malignancies

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00649584

Enrollment

Registered

2008-04-01

Start date

2008-03-31

Completion date

2010-02-28

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, monomethyl auristatin E, Combined Modality Therapy, Drug Therapy, Immunotherapy, Lymphoma, Non-Hodgkin, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Hematologic Diseases, Lymphoma

Brief 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.

Interventions

DRUGSGN-35

IV; 0.4 up to 1.8 mg/kg weekly 3 out of 4 weeks; minimum of two 28-day cycles

DRUGgemcitabine

IV; 1000 mg/m2 weekly 3 out of 4 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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.

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: Feb 4, 2026