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
- Diseases
- Multiple myeloma
- 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
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Princess Margaret Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Completed |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Completed |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea Seoul St Marys Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kaohsiung Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.