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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505584-36-00 | Registry Identifier | EUCT number |
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The purpose of this study is to characterize safety and to determine the Recommended Phase 2 Dose (RP2D[s]) and optimal dosing schedule(s) of JNJ-88549968 in part 1 (Dose Escalation); to characterize the safety of JNJ- 88549968 at RP2D(s) in part 2 (Cohort Expansion). For U.S. sites: the purpose of this study is to characterize the safety and to determine the RP2D(s) and optimal dosing schedule(s) of JNJ-88549968 in Part 1 and part 1b (Dose Escalation), and to characterize the safety of JNJ-88549968 at the RP2D(s) in Part 2 and part 2b (Cohort Expansion), when given as monotherapy in essential thrombocythemia (ET) or myelofibrosis (MF), and with ruxolitinib or momelotinib in MF only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation (Part 1), Dose Expansion (Part 2) and Part 1b (US only), Part 2b (US only) | Experimental | In dose escalation (Part 1), participants will receive JNJ-88549968. For myelofibrosis (MF) participants only, the study will explore a Phase 1b cohort in which the janus kinase (JAK) inhibitor ruxolitinib or momelotinib is started in combination with JNJ-88549968. The dose will be escalated sequentially to determine the recommended phase 2 dose (RP2D) and optimal dosing schedule (s) based on safety, pharmacokinetic, pharmacodynamic, and preliminary assessment of efficacy across several dose regimens. In dose expansion (Part 2, Part 2b [US only]), participants will receive JNJ-88549968 at the RP2D regimen(s) determined in dose escalation (Part 1, Part 1b [US only]). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-88549968 | Drug | JNJ-88549968 will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1, Part 1b (US Only): Number of Participants With Dose Limiting Toxicity (DLT) | Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. For US only: A DLT is any adverse event attributed to study treatment that meets the criteria for severity and duration and that occurs during the evaluation periods unless it can be incontrovertibly attributed to disease or other extraneous cause such as an accident. | Approximately up to 35 days after first dose of study treatment |
| Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants with Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. | Up to 2 years |
| Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants with Adverse Events (AEs) by Severity | An adverse event is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event. Cytokine release syndrome (CRS) and associated neurologic toxicity events (immune effector cell-associated neurotoxicity syndrome events [ICANS]) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1, 2, Part 1b (US Only), Part 2b (US Only): Serum Concentration of JNJ-88549968 | Serum samples will be analyzed to determine concentrations of JNJ-88549968. | Up to 2 years |
| Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants With Presence of Anti-Drug Antibodies to JNJ-88549968 |
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Inclusion Criteria:
Exclusion Criteria:
Known allergies, hypersensitivity, or intolerance to the excipients of the study treatment
Concurrent or recently diagnosed or treated malignancies present at the time of participant screening. Exceptions are squamous and basal cell carcinoma of the skin, carcinoma in situ of the cervix, and any malignancy that is considered cured or has minimal risk of recurrence within 1 year of first dose of study treatment in the opinion of both the investigator and sponsor's medical monitor. Participants cured of another malignant disease with no sign of relapse greater than or equal to (>=) 3 years after treatment ended are allowed to enter the study
Prior solid organ transplantation
Either of the following regarding hematopoietic stem cell transplantation:
History of clinically significant cardiovascular disease within 6 months prior to the first dose of study treatment
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States | |
| UCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer Center |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Ruxolitinib | Drug | For US sites: Ruxolitinib will be administered for participants with MF only. |
|
| Momelotinib | Drug | For US sites: Momelotinib will be administered for participants with MF only. |
|
Number of participants with presence of anti-drug antibodies to JNJ-88549968 will be reported. |
| Up to 2 years |
| Part 1, 2, Part 1b (US Only), Part 2b (US Only): Overall Response Rate | ORR is defined as the percentage of participants who achieve partial response (PR) and complete response (CR) according to modified International Working Group-Myeloproliferative Neoplasm Research and Treatment (IWG-MRT) criteria and modified European Leukemia Net (ELN) consensus report. | Up to 2 years |
| Part 1, 2, Part 1b (US Only), Part 2b (US Only): Complete Response (CR) Rate | CR rate is defined as the percentage of participants who achieve a best response of CR according to disease as defined in modified IWG-MRT criteria and modified ELN consensus report. | Up to 2 years |
| Part 1, 2, Part 1b (US Only), Part 2b (US Only): Time to Response (TTR) | TTR is defined for participants who achieved PR or CR as the time from the first dose of study treatment to first response of PR or CR according to modified IWG-MRT criteria and modified ELN consensus report. | Up to 2 years |
| Part 1, 2, Part 1b (US Only), Part 2b (US Only): Duration of Response (DOR) | DOR is defined for participants who achieved PR or CR as the time between the date of initial documentation of PR or CR to the date of first documented evidence of disease progression, as defined in modified IWG-MRT criteria and modified ELN consensus report, or death, whichever comes first. | Up to 2 years |
| Part 2, Part 2b (US Only): Change From Baseline in Myeloproliferative Neoplasm (MPN) Symptom Burden | Change from baseline in MPN symptom burden assessed using patient reported outcome (PRO) questionnaire will be reported in this outcome measure. | Baseline up to 2 years |
| Recruiting |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Moffit Cancer center | Recruiting | Tampa | Florida | 33612 | United States |
| Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
| Montefiore Medical Center | Recruiting | The Bronx | New York | 10467 | United States |
| Levine Cancer Institute | Recruiting | Charlotte | North Carolina | 28204 | United States |
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Sarah Cannon Cancer Institute | Recruiting | Nashville | Tennessee | 37203 | United States |
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| Princess Margaret Cancer Centre University Health Network | Recruiting | Toronto | Ontario | M5G 1Z5 | Canada |
| Jewish General Hospital | Recruiting | Montreal | Quebec | H3T 1E2 | Canada |
| Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences | Recruiting | Tianjin | 301617 | China |
| Hopital Saint Louis | Recruiting | Paris | 75475 | France |
| CH LYON SUD - Hematology | Recruiting | Pierre-Bénite | 69495 | France |
| Institut Universitaire du Cancer Toulouse Oncopole | Recruiting | Toulouse | 31059 | France |
| Universitaetsklinikum der RWTH Aachen | Recruiting | Aachen | 52074 | Germany |
| Charite Campus Benjamin Franklin | Recruiting | Berlin | 12203 | Germany |
| Med. Universitatsklinik Essen | Recruiting | Essen | 45147 | Germany |
| Medizinische Hochschule Hannover | Recruiting | Hanover | 30625 | Germany |
| Universitaetsklinikum Heidelberg | Recruiting | Heidelberg | 69120 | Germany |
| Universitaetsklinikum Regensburg | Recruiting | Regensburg | 93053 | Germany |
| Carmel Medical Center | Recruiting | Haifa | 3436212 | Israel |
| Hadassah University Hospita Ein Kerem | Recruiting | Jerusalem | 9112001 | Israel |
| Sheba Medical Center | Recruiting | Ramat Gan | 5266202 | Israel |
| Tel Aviv Sourasky Medical Center | Recruiting | Tel Aviv | 64239 | Israel |
| Policlinico Sant'Orsola Malpighi | Recruiting | Bologna | 40138 | Italy |
| Policlinico di Milano | Recruiting | Milan | 21022 | Italy |
| Juntendo University Hospital | Recruiting | Bunkyō City | 113 8431 | Japan |
| National Cancer Center Hospital East | Recruiting | Kashiwa | 277 8577 | Japan |
| Hosp. Univ. Germans Trias I Pujol | Recruiting | Badalona | 08916 | Spain |
| Hosp. Clinico Univ. de Valencia | Recruiting | Valencia | 46010 | Spain |
| University College London Hospitals Nhs Foundation Trust | Recruiting | London | NW1 2PG | United Kingdom |
| Guy's and St Thomas' Hospital | Recruiting | London | SE1 9RT | United Kingdom |
| Churchill Hospital | Recruiting | Oxford | OX3 7LE | United Kingdom |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
| C546012 | N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide |
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