SHS_492354 BENW CSEG 16172

Phase 1 Study of SGN-CD352A in Patients With Relapsed or Refractory Multiple Myeloma

This study tests the safety of a drug called SGN-CD352A, to find out what its side effects are. SGN-CD352A will be given every 4 weeks to a small group of patients with multiple myeloma. The study will have 2 parts. In the first part, different doses of SGN-CD352A will be given to different patients (each individual patient will get the same dose for all treatments). The doses will be very low at the start of the trial, and will increase only when the lower dose levels are proven safe. In the second part of the study, up to 2 dose levels that are both safe and show promising activity against MM will be given to more patients.

Inclusion Criteria:

•Diagnosis of MM requiring systemic therapy (per the International Myeloma Working Group [IMWG] ).
•Age 18 years or older.
•An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
•Life expectancy greater than months.
•Received at least 2 prior lines of therapy for MM including an immunomodulatory drug and a proteasome inhibitor.
•Measurable disease, as defined by at least one of the following: Serum M protein 0.5 g/dL or higher, Urine M protein 200 mg/24 hr or higher, Abnormal serum free light chain (SFLC) ratio.
•Adequate hematologic, renal, and hepatic function
•A negative pregnancy test (for females of childbearing potential).
•Patients must provide written informed consent.

Exclusion Criteria:

•Other invasive malignancy within the past 3 years.
•Active cerebral/meningeal disease related to the underlying malignancy.
•Active Grade 3 or higher infection.
•Known to be positive for HIV or known to have active hepatitis B or C.
•Previous allogeneic stem cell transplant.
•Idiopathic interstitial pneumonia or impaired diffusion capacity of the lung for carbon monoxide (DLCO).
•Cerebrovascular or cardiovascular event, or congestive heart failure within the last 6 months.
•Females who are pregnant or breastfeeding.
Phase I
William Bensinger, M.D.
Seattle Genetics Inc.
Tenzin Tsomo
  • Swedish Medical Center