Phase 1 Study of SGN-CD352A in Patients With Relapsed or Refractory Multiple Myeloma
Overview
- Phase
- Phase 1
- Intervention
- SGN-CD352A
- Conditions
- Multiple Myeloma
- Sponsor
- Seagen Inc.
- Enrollment
- 27
- Locations
- 11
- Primary Endpoint
- Type, incidence, severity, seriousness, and relatedness of adverse events (including laboratory abnormalities)
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
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
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
Investigators
Eligibility Criteria
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
- •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.
Arms & Interventions
(Dose Escalation) Cohort -1 - 6
SGN-CD352A will be given intravenously (into a vein; IV) every 28 days at increasing doses.
Intervention: SGN-CD352A
Outcomes
Primary Outcomes
Type, incidence, severity, seriousness, and relatedness of adverse events (including laboratory abnormalities)
Time Frame: Through 1 month following last dose.
Incidence of dose-limiting toxicity
Time Frame: During Cycle 1 (Trial Days 1-28)
Secondary Outcomes
- Complete response rate(Up to approximately 3 years)
- Incidence of antitherapeutic antibodies (ATA)(Up to approximately 3 years)
- Overall survival(Up to approximately 3 years)
- Duration of objective response(Up to approximately 3 years)
- Duration of complete response(Up to approximately 3 years)
- Progression-free survival(Up to approximately 3 years)
- Blood concentrations of SGN-CD352A and metabolites(Up to approximately 3 years)
- Objective response rate(Up to approximately 3 years)