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

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ClinicalTrials.gov Identifier: NCT03379584
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
This study will test the safety and activity of SGN-CD48A given every 3 weeks to patients with multiple myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: SGN-CD48A Phase 1

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of SGN-CD48A in Patients With Relapsed or Refractory Multiple Myeloma
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: SGN-CD48A
SGN-CD48A every 3 weeks
Drug: SGN-CD48A
Intravenous (IV) infusion every 3 weeks




Primary Outcome Measures :
  1. Type, incidence, severity, seriousness, and relatedness of adverse events [ Time Frame: Through 1 month following last dose ]
  2. Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ]
  3. Incidence of dose limiting toxicity [ Time Frame: Through 3 weeks following first dose ]

Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: Through 1 month following last dose ]
    The proportion of patients with stringent complete response, complete response, very good partial response, or partial response per investigator

  2. Complete response rate [ Time Frame: Through 1 month following last dose ]
    The proportion of patients with stringent complete response or complete response per investigator

  3. Duration of objective response [ Time Frame: Up to approximately 3 years ]
  4. Duration of complete response [ Time Frame: Up to approximately 3 years ]
  5. Progression-free survival [ Time Frame: Up to approximately 3 years ]
  6. Overall survival [ Time Frame: Up to approximately 3 years ]
  7. Blood concentrations of SGN-CD48A and metabolites [ Time Frame: Through 1 month following last dose ]
  8. Incidence of antitherapeutic antibodies [ Time Frame: Through 1 month following last dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379584


Contacts
Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
United States, California
University of California at San Francisco Recruiting
San Francisco, California, United States, 94134
Contact: Thomas Martin    415-353-9365    tom.martin@ucsf.edu   
Principal Investigator: Thomas Martin         
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06520
Contact: Terri Parker    203-737-5312    terri.parker@yale.edu   
Principal Investigator: Terri Parker, MD         
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Jason Brayer    813-745-4294    jason.brayer@moffitt.org   
Principal Investigator: Jason Brayer         
United States, Pennsylvania
University of Pennsylvania / Perelman Center for Advanced Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Adam Cohen    215-615-7362    adam.cohen@uphs.upenn.edu   
Principal Investigator: Adam Cohen         
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Suzanne McGoldrick, MD, MPH Seattle Genetics, Inc.

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT03379584     History of Changes
Other Study ID Numbers: SGN48A-001
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 31, 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Seattle Genetics, Inc.:
Multiple myeloma
Antibody-drug conjugate

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases