A Safety/Efficacy Study of SGN-30 (Antibody) in Patients With Refractory or Recurrent CD30+ Hematologic Malignancies
Status:
Completed
Trial end date:
2003-08-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate a multi-dose regimen of SGN-30, a novel chimeric
monoclonal antibody (mAb), in patients with refractory or recurrent CD30+ hematologic
malignancies.
This is a single-arm, open-label phase I/II study designed to define the toxicity profile,
pharmacokinetic (PK) profile, and anti-tumor activity of a multi-dose regimen of SGN-30 in
patients with refractory or recurrent CD30+ hematologic malignancies. The phase I study will
be a modified dose escalation of SGN-30. Based on preclinical pharmacology and toxicokinetics
(TK) and the first use in human single-dose phase I study, SGN-30 will be administered on a
weekly schedule. An initial dose of 2 mg/kg will escalate until the maximum tolerated dose
(MTD) has been reached or until a weekly dose of 12 mg/kg is achieved.