A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-87562761 in Relapsed/Refractory Multiple Myeloma
| Registry | NCT06604715 |
|---|---|
| Status | Active not recruiting |
| Phase | Phase 1 |
| Study type | Interventional; na, sequential, masking: none, treatment |
| Enrollment | 17 (Actual) |
| Sponsor | Janssen Research & Development, LLC (Industry) |
| Conditions | Relapsed or Refractory Multiple Myeloma |
| Interventions | JNJ-87562761 (Drug) |
| Dates | start 2024-12-19, primary completion 2027-11-03 (estimated), completion 2027-11-15 (estimated), first posted 2024-09-19, last updated 2026-09-25 |
| Locations | 15 sites in Canada, South Korea, Spain, Taiwan |
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All trials for Relapsed or Refractory Multiple Myeloma All trials of JNJ-87562761
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| JNJ-87562761 | Experimental | Drug: JNJ-87562761 | Participants will receive JNJ-87562761 during the Part 1 (Dose escalation) to determine the recommended phase 2 dose (RP2D) regimen(s). The dose will be escalated sequentially until the RP2D regimen(s) have been identified. In Part 2 (Dose expansion) participants will receive JNJ-87562761 at the RP2D regimen(s) determined in Part 1. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * 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 Exclusion Criteria: * Active plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or immunoglobulin light chain amyloidosis * 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 * 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 * 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) * 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 \[etc.\])
| Facility | City | Country | Status |
|---|---|---|---|
| Princess Margaret Hospital | Toronto, Ontario | Canada | |
| Jewish General Hospital | Montreal, Quebec | Canada | |
| Seoul National University Hospital | Seoul | South Korea | |
| Asan Medical Center | Seoul | South Korea | |
| Samsung Medical Center | Seoul | South Korea | |
| The Catholic University of Korea Seoul St Marys Hospital | Seoul | South Korea | |
| Hosp. Univ. Germans Trias I Pujol | Badalona | Spain | |
| Hosp Clinic de Barcelona | Barcelona | Spain | |
| Hosp Univ Fund Jimenez Diaz | Madrid | Spain | |
| Clinica Univ. de Navarra | Pamplona | Spain | |
| Hosp Clinico Univ de Salamanca | Salamanca | Spain | |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | Taiwan | |
| China Medical University Hospital | Taichung | Taiwan | |
| National Cheng Kung University Hospital | Tainan | Taiwan | |
| National Taiwan University Hospital | Taipei | Taiwan |