NCT03379584

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1 multiple-myeloma

Timeline
Completed

Started Feb 2018

Shorter than P25 for phase_1 multiple-myeloma

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 20, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2019

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

1.5 years

First QC Date

December 13, 2017

Last Update Submit

September 16, 2019

Conditions

Multiple Myeloma

Keywords

Multiple myelomaAntibody-drug conjugate

Outcome Measures

Primary Outcomes (3)

  • Type, incidence, severity, seriousness, and relatedness of adverse events

    Through 1 month following last dose

  • Incidence of laboratory abnormalities

    Through 1 month following last dose

  • Incidence of dose limiting toxicity

    Through 3 weeks following first dose

Secondary Outcomes (8)

  • Objective response rate

    Through 1 month following last dose

  • Complete response rate

    Through 1 month following last dose

  • 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

  • +3 more secondary outcomes

Study Arms (1)

SGN-CD48A

EXPERIMENTAL

SGN-CD48A

Drug: SGN-CD48A

Interventions

SGN-CD48ADRUG

Intravenous (IV) infusion on days 1, 8, and 15 of a 28-day cycle

SGN-CD48A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of California at San Francisco

San Francisco, California, 94134, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

University of Pennsylvania / Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Suzanne McGoldrick, MD, MPH

    Seagen Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2017

First Posted

December 20, 2017

Study Start

February 20, 2018

Primary Completion

August 23, 2019

Study Completion

August 23, 2019

Last Updated

September 18, 2019

Record last verified: 2019-09

Locations

US(6)