A Phase 1, First-in-Human, Dose Escalation Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The purpose of Part 1 (Dose Escalation) of the study is to assess the safety and tolerability, and to identify the recommended Phase 2 dose\[s\] (RP2D\[s\]) in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) (that is a type of blood cancer that has come back after treatment/or has stopped responding to treatment) or R/R higher-risk type of myelodysplastic neoplasms (MDS, type of blood cancer). The purpose of Part 2 (Cohort Expansion) is to further assess the safety, tolerability and efficacy in participants with R/R AML or higher-risk types of MDS.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Have a diagnosis, per World Health Organization (WHO) 2022 criteria of:

‣ relapsed/refractory acute myeloid leukemia (AML)

⁃ relapsed/refractory moderate high, high, or very high risk myelodysplastic neoplasms (MDS) per Molecular International Prognostic Scoring System (IPSS-M)

• Body weight greater than or equals to (\>=) 40 kilograms (kg)

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 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)

• Participants must have laboratory parameters in the required range

Locations
Other Locations
Canada
Arthur J E Child Comprehensive Cancer Centre
RECRUITING
Calgary
Princess Margaret Hospital
RECRUITING
Toronto
Vancouver General Hospital
RECRUITING
Vancouver
Spain
Hosp Clinic de Barcelona
RECRUITING
Barcelona
Hosp Univ Fund Jimenez Diaz
RECRUITING
Madrid
Clinica Univ. de Navarra
RECRUITING
Pamplona
United Kingdom
Addenbrookes Hospital
RECRUITING
Cambridge
University College London Hospitals
RECRUITING
London
The Christie NHS Foundation Trust Christie Hospital
RECRUITING
Manchester
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2025-01-14
Estimated Completion Date: 2028-08-15
Participants
Target number of participants: 100
Treatments
Experimental: JNJ-89853413
Participants will receive JNJ-89853413 in Part 1 (Dose escalation) of the study and the dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified. Participants in Part 2 (Dose expansion) will receive JNJ-89853413 at the RP2D determined in Part 1.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov

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