Testing JNJ-90189892 for patients with relapsed or refractory acute myeloid leukemia or myelodysplastic neoplasms
A Phase 1, First-in-Human, Dose Escalation Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
PHASE1 · Janssen Research & Development, LLC · NCT06651229
This study is testing a new treatment called JNJ-90189892 to see if it can help people with relapsed or hard-to-treat acute myeloid leukemia or myelodysplastic neoplasms feel better and stay safe.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 155 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Janssen Research & Development, LLC (industry) |
| Locations | 9 sites (Concord and 8 other locations) |
| Trial ID | NCT06651229 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effective dosing of JNJ-90189892 in patients with relapsed or refractory acute myeloid leukemia (AML) or higher-risk myelodysplastic neoplasms (MDS). It consists of two parts: the first part focuses on dose escalation to determine the recommended Phase 2 doses, while the second part expands the cohort to further assess safety, tolerability, and efficacy. Participants will be monitored closely to gather data on how well the treatment works and its side effects.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with relapsed or refractory AML or higher-risk MDS who meet specific health criteria.
Not a fit: Patients with significant pulmonary issues or uncontrolled infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat blood cancers.
How similar studies have performed: Other studies have shown promise with similar approaches in treating blood cancers, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A. For Parts 1, 2, and 3: Have a diagnosis, per the world health organization (WHO) 2022 criteria, of (a) Parts 1, 2, and 3: Acute myeloid leukemia (AML) or (b) Parts 1 and 2: Moderate high, high, or very high-risk myelodysplastic neoplasms (MDS) per Molecular International Prognostic Scoring System (IPSS-M); B. For Part 4 only: Previously untreated acute myeloid leukemia (AML) per the WHO 2022 criteria * Body weight that is greater than or equals to (\>=) 40 kg * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Have adequate renal function defined as Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Estimated Glomerular Filtration Rate (eGFR) \>=40 milligrams per minute (mL/min) computed with the calculator on the national kidney foundation website * Participants must have laboratory parameters in the required range Exclusion Criteria: * Has a medical history of clinically significant pulmonary compromise, particularly the current need for supplemental oxygen use to maintain adequate oxygenation * Has evidence of uncontrolled systemic viral, bacterial, or fungal infection. Antimicrobial prophylaxis is permitted * All participants- Has known allergies, hypersensitivity, or intolerance to JNJ-90189892 or its excipients; Parts 3 and 4- Has known allergies, hypersensitivity, or intolerance to venetoclax (VEN), azacitadine (AZA), or their excipients * Had major surgery or had significant traumatic injury within 14 days of planned first dose of JNJ-90189892 * Had a prior or concurrent second malignancy with natural history or treatment likely to interfere with any study endpoints of safety or the efficacy of the study treatment * Has known active central nervous system involvement
Where this trial is running
Concord and 8 other locations
- Concord Hospital — Concord, Australia (RECRUITING)
- Peter MacCallum Cancer Centre — Melbourne, Australia (RECRUITING)
- Sir Charles Gairdner Hospital — Nedlands, Australia (RECRUITING)
- Institut Paoli-Calmettes — Marseille, France (RECRUITING)
- Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre — Strasbourg, France (RECRUITING)
- Institut Claudius Regaud — Toulouse, France (RECRUITING)
- Hosp Univ Fund Jimenez Diaz — Madrid, Spain (RECRUITING)
- Clinica Univ. de Navarra — Pamplona, Spain (RECRUITING)
- Hospital Universitario Virgen Rocio — Seville, Spain (RECRUITING)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Leukemia, Myeloid, Acute, Myelodysplastic Neoplasms