Lymphoma, B-Cell Clinical Trial
Official title:
A Phase I/II Multi-Dose Study of SGN-30 in Patients With Refractory or Recurrent CD30+ Hematologic Malignancies
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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