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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-07-17

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.

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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

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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(Dose Escalation) Cohort -1 - 6

SGN-CD352A will be given intravenously (into a vein; IV) every 28 days at increasing doses.

Group Type EXPERIMENTAL

SGN-CD352A

Intervention Type DRUG

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.

Interventions

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SGN-CD352A

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.

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No