A Safety Study of SGN-CD352A for Patients With Relapsed/Refractory Multiple Myeloma

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: SGN-CD352A


Participation Criteria
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Eligibility Criteria
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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 3 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, Serum free light chain (SFLC) 10 mg/dL or higher, and Abnormal 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (Dose Escalation) Cohort -1 - 6<br>SGN-CD352A will be given intravenously (into a vein; IV) every 28 days at increasing doses. | Drug: SGN-CD352A<br>* On the first day of each 28-day cycle, SGN-CD352A will be given IV. The dose of SGN-CD352A is different in each cohort of the study, with the lowest dose in Cohort -1 (4 mcg/kg) and the highest in Cohort 6 (65 mcg/kg). Patients can only be enrolled into a higher dose level arm if lower doses have proven safe.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type, incidence, severity, seriousness, and relatedness of adverse events (including laboratory abnormalities) |  | Through 1 month following last dose. | 
| Incidence of dose-limiting toxicity |  | During Cycle 1 (Trial Days 1-28) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Up to approximately 3 years | 
| Progression-free survival |  | Up to approximately 3 years | 
| Duration of objective response |  | Up to approximately 3 years | 
| Duration of complete response |  | Up to approximately 3 years | 
| Objective response rate |  | Up to approximately 3 years | 
| Complete response rate |  | Up to approximately 3 years | 
| Incidence of antitherapeutic antibodies (ATA) |  | Up to approximately 3 years | 
| Blood concentrations of SGN-CD352A and metabolites |  | Up to approximately 3 years |