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NCT06604715Active, not recruitingPhase 1

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

A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-87562761 in Relapsed/Refractory Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
17 (actual)
First submitted
18 Sept 2024
Start date
19 Dec 2024
Primary completion date
3 Nov 2027
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT06604715
EU CT number
2024-513439-25-00

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 17
  • From 19 Dec 2024 to the primary completion date, 3 Nov 2027
  • 15 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration
  • Live, attenuated vaccine within 4 weeks before the first dose of study treatment
  • Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline level or to less than or equal to (\<=) Grade 1 (except alopecia, tissue post-RT fibrosis, or Grade \< 3 peripheral neuropathy)
  • Received a cumulative dose of corticosteroids equivalent to greater than or equal to (\>=) 140 mg of prednisone within the 14-day period before the start of study treatment administration
  • Prior antitumor therapy in the specified time frame prior to the first dose of study treatment: (Targeted therapy, epigenetic therapy, monoclonal antibody treatment, or treatment with an investigational drug or an invasive investigational medical device or conventional chemotherapy within 21 days, gene-modified adoptive cell therapy or treatment with anti-CD38 directed therapies within 3 months, proteasome inhibitor \[PI\] therapy or radiotherapy within 14 days, or immunomodulatory drug (IMiD) agent therapy within 7 days)

Other illness

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

Lab values

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

Other

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

Who the study is looking for

  • Relapsed, refractory multiple myeloma with measurable disease defined as: (a) Serum monoclonal 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) \>10 milligrams per deciliter (mg/dL) and abnormal serum immunoglobulin kappa-lambda FLC ratio
  • Must have had prior therapy including a proteasome inhibitor, immunomodulatory agent and 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 per 2021 chronic kidney disease epidemiology collaboration (CKD-EPI) creatinine equation
  • While on study treatment and for 6 months after the last dose of study treatment, a participant must: (a) Not breastfeed or be pregnant; (b) Not donate gametes (that is, eggs or sperm) or freeze for future use for the purposes of assisted reproduction; (c) Wear an external condom

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Jewish General Hospital
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Princess Margaret Hospital
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TorontoCanadaUnknown status
Institut Catala d'Oncologia
Coordinator of this site? Confirm its status
BadalonaSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital Universitario Fundación Jiménez Díaz
Coordinator of this site? Confirm its status
MadridSpainCompleted
Clínica Universidad de navarra
Coordinator of this site? Confirm its status
PamplonaSpainCompleted
Hospital Universitario De Salamanca
Coordinator of this site? Confirm its status
SalamancaSpainCompleted
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
The Catholic University of Korea Seoul St Marys Hospital
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Kaohsiung Chang Gung Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.