A Phase I, First-in-Human, Open-Label, Dose Escalation Study of JNJ-64007957, a Humanized BCMA x CD 3 DuoBody Antibody in Subjects with Relapsed or Refractory Multiple Myeloma

Overview

The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for JNJ-64007957 and to characterize the safety and tolerability of JNJ-64007957 at the RP2Ds.

SparkCures ID 878
Trial Phase Phase 1
Enrollment 60 Patients
Treatments
Trial Sponsors
  • Janssen Research & Development
NCT Identifier

NCT03145181

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Documented diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
  • Measurable multiple myeloma that is relapsed or refractory to established therapies with known clinical benefit in relapsed/refractory multiple myeloma or be intolerant of those established multiple myeloma therapies, and a candidate for JNJ-64007957 treatment in the opinion of the treating physician. Prior lines of therapy must include a proteasome inhibitor and an immunomodulatory drug in any order during the course of treatment. Participants who could not tolerate a proteasome inhibitor or immunomodulatory drugs are allowed
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Women of childbearing potential and fertile men who are sexually active must agree to use a highly effective method of contraception (less than [<] 1 percent [%] / year failure rate) during the study and for 90 days after the last dose of study drug. Contraception must be consistent with local regulations regarding the use of birth control methods for participants participating in clinical trials. Women and men must agree not to donate eggs (ova, oocytes) or sperm, respectively, during the study and for 90 days after the last dose of study drug
  • Participants must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease

Exclusion Criteria:

  • Prior treatment with any B cell maturation antigen (BCMA) targeted therapy
  • Prior antitumor therapy including: chemotherapy, targeted therapy, immunotherapy, radiotherapy or treatment with an investigational drug or used an invasive investigational medical device within 3 weeks or at least 5 half-lives prior to the first dose of study drug, whichever is less
  • Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
  • Received a cumulative dose of corticosteroids equivalent to greater than or equal to (>=) 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
  • Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

California
Massachusetts
New York
North Carolina
Pennsylvania
International Locations

This trial has active trial locations in countries outside of the United States.

Our system currently only provides clinical trial matching services for myeloma patients in the United States.

You can view this clinical trial's international locations by visiting ClinicalTrials.gov. Please note the information provided through the government website may be inaccurate and/or out-dated.

Resources

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