A Safety Study of SGN-CD48A in Patients With Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

A Phase 1 Study of SGN-CD48A in Patients With Relapsed or Refractory Multiple Myeloma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03379584
• Other study ID #: SGN48A-001
• Status: Terminated
• Phase: Phase 1
• Start date: February 20, 2018
• Est. completion date: August 23, 2019

Study information

• Verified date: September 2019
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will test the safety and activity of SGN-CD48A in patients with multiple myeloma. SGN-CD48A will be given on Days 1, 8, and 15 of a 28-day cycle. Prior to protocol amendment 2, SGN-CD48A was given every 3 weeks.

Description:

This study is designed to evaluate the safety, tolerability, and antitumor activity of SGN-CD48A in patients with relapsed or refractory multiple myeloma. This study will be conducted in 2 parts:

1. Dose escalation: This part will evaluate increasing doses of SGN-CD48A to identify the maximum tolerated dose.

The first group of patients enrolled on the study will receive the lowest dose of SGN-CD48A. Once this dose is shown to be safe, a second group of patients will be enrolled at the next higher dose. Patients will continue to be enrolled in groups receiving increasing doses until the maximum tolerated dose level is reached. Patients can only be enrolled into a higher dose level once the lower doses have been demonstrated safe. Dose escalation will be conducted using a modified toxicity probability interval (mTPI) study design.

2. Dose expansion: This part will further evaluate the safety, tolerability, and antitumor activity of up to 2 dose levels of SGN-CD48A shown to be safe in the first part of the trial.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: August 23, 2019
• Est. primary completion date: August 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of MM requiring systemic therapy (per the International Myeloma Working Group [IMWG])

• Patients must not have other therapeutic options known to provide clinical benefit in MM available to them. Prior lines of therapy must include at least a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.

• Measureable 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 hour or higher, and serum immunoglobulin free light chain 10 mg/dL or higher and abnormal serum immunoglobulin kappa lambda free light chain ratio

• Adequate hematologic, renal, and hepatic function

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Life expectancy greater than 3 months

• A negative pregnancy test (for females of childbearing potential)

• Patients must provide written consent

Exclusion Criteria:

• Pre-existing peripheral neuropathy Grade 2 or higher

• History of malignancy other than MM within the past 3 years

• Active cerebral/meningeal disease related to the underlying malignancy

• Uncontrolled Grade 3 or higher infection

• Known to be positive for HIV or hepatitis B, or known to have active hepatitis C infection

• Previous allogeneic stem cell transplant

• History of cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with congestive heart failure within the last 6 months

• Treatment with any known P-gp inducers/inhibitors or strong CYP3A inhibitors within 14 days prior to the first dose of study drug

• Prior antitumor therapy that is not completed at least 4 weeks prior to first dose of study drug, or at least 2 weeks if progressing. Prior CAR T-cell therapy must be completed 8 weeks before first dose of study drug.

• Females who are pregnant or breastfeeding

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• SGN-CD48A
Intravenous (IV) infusion on days 1, 8, and 15 of a 28-day cycle

Locations

Country	Name	City	State
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Yale Cancer Center	New Haven	Connecticut
United States	Mount Sinai Medical Center	New York	New York
United States	University of Pennsylvania / Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania
United States	University of California at San Francisco	San Francisco	California
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type, incidence, severity, seriousness, and relatedness of adverse events		Through 1 month following last dose
Primary	Incidence of laboratory abnormalities		Through 1 month following last dose
Primary	Incidence of dose limiting toxicity		Through 3 weeks following first dose
Secondary	Objective response rate	The proportion of patients with stringent complete response, complete response, very good partial response, or partial response per investigator	Through 1 month following last dose
Secondary	Complete response rate	The proportion of patients with stringent complete response or complete response per investigator	Through 1 month following last dose
Secondary	Duration of objective response		Up to approximately 3 years
Secondary	Duration of complete response		Up to approximately 3 years
Secondary	Progression-free survival		Up to approximately 3 years
Secondary	Overall survival		Up to approximately 3 years
Secondary	Blood concentrations of SGN-CD48A and metabolites		Through 1 month following last dose
Secondary	Incidence of antitherapeutic antibodies		Through 1 month following last dose