A Study of JNJ-87562761 in Participants With Relapsed or Refractory Multiple Myeloma

Last updated: July 18, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

1

Condition

Bone Neoplasm

Bone Diseases

Cancer/tumors

Treatment

JNJ-87562761

Clinical Study ID

NCT06604715
87562761MMY1001
2024-513439-25-00
87562761MMY1001
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine the recommended phase 2 dose(s) (RP2D[s]) of JNJ-87562761 in Part 1 (dose escalation), and to determine the safety and tolerability at RP2D in Part 2 (dose expansion) in participants with multiple myeloma (MM) whose disease has come back after treatment (relapsed) or hasn't responded to treatment (refractory).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Relapsed, refractory multiple myeloma with measurable disease defined as: (a) Serummonoclonal paraprotein (M-protein) level greater than (>)0.5 grams per deciliter (g/dL); or (b) Urine M-protein level >200 milligrams per 24 hours (mg/24 hours); or (c) Light chain multiple myeloma: serum immunoglobulin free light chain (FLC) >10milligrams per deciliter (mg/dL) and abnormal serum immunoglobulin kappa-lambda FLCratio

  • Must have had prior therapy including a proteasome inhibitor, immunomodulatory agentand anti-CD38 therapy

  • Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

  • Have an estimated glomerular filtration rate (eGFR), of > 30 millilitres (mL)/min/1.73 meter square (m^2) computed with the online calculator on the chronickidney disease epidemiology collaboration (CKD-EPI) by use of the CKD-EPI serumcreatinine (cr) result

  • While on study treatment and for 6 months after the last dose of study treatment, aparticipant must: (a) Not breastfeed or be pregnant; (b) Not donate gametes (thatis, eggs or sperm) or freeze for future use for the purposes of assistedreproduction; (c) Wear an external condom

Exclusion

Exclusion Criteria:

  • Active plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), orimmunoglobulin light chain amyloidosis

  • Prior allogeneic transplant within 6 months before the start of study treatmentadministration or autologous transplant within 12 weeks before the start of studytreatment administration

  • Live, attenuated vaccine within 4 weeks before the first dose of study treatment

  • Central Nervous System (CNS) involvement or clinical signs of meningeal involvementof multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI)and lumbar cytology are required

  • Non-hematologic toxicity from prior anticancer therapy that has not resolved tobaseline level or to less than or equal to (<=) Grade 1 (except alopecia, tissuepost-RT fibrosis, or Grade < 3 peripheral neuropathy)

  • Received a cumulative dose of corticosteroids equivalent to greater than (>) 140 mgof prednisone within the 14-day period before the start of study treatmentadministration

  • Prior antitumor therapy in the specified time frame prior to the first dose of studytreatment: (Targeted therapy, epigenetic therapy, monoclonal antibody treatment, ortreatment with an investigational drug or an invasive investigational medical deviceor conventional chemotherapy within 21 days, gene-modified adoptive cell therapy ortreatment with anti-CD38 directed therapies within 3 months, proteasome inhibitor [PI] therapy or radiotherapy within 14 days, or immunomodulatory drug (IMiD) agenttherapy within 7 days)

  • Following medical conditions: pulmonary compromise requiring supplemental oxygen useto maintain adequate oxygenation, human immunodeficiency (HIV) infection (participants with a detectable viral load or low CD4 count), active hepatitis B orC infection, active autoimmune disease requiring systemic immunosuppressive therapywithin 6 months before start of study treatment, serious uncontrolled ongoing viralor bacterial or systemic fungal infection, cardiac conditions (myocardial infarction <=6 months prior to enrollment, New York Heart Association stage III or IVcongestive heart failure, et cetera [etc.] )

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: JNJ-87562761
Phase: 1
Study Start date:
December 19, 2024
Estimated Completion Date:
November 30, 2028

Connect with a study center

  • Princess Margaret Hospital

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 137 701
    Korea, Republic of

    Active - Recruiting

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916
    Spain

    Active - Recruiting

  • Hosp Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Clinica Univ. de Navarra

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Hosp Clinico Univ de Salamanca

    Salamanca, 57007
    Spain

    Active - Recruiting

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