The purpose of this study is to characterize the safety and tolerability of JNJ-63709178 and identify the recommended Phase 2 dose(s) (RP2D) and schedule for JNJ-63709178 in Part 1 and to characterize the safety and tolerability of JNJ-63709178 at the RP2D(s) in Part 2.
This is first-in-human (FIH) Phase 1, open-label (identity of assigned study drug will be known), multicenter, dose escalation study with dose expansion to identify the RP2D and to evaluate the safety, tolerability, and preliminary antitumor activity of JNJ-63709178 in adult participants with relapsed or refractory acute myeloid leukemia (AML) who are ineligible for or have exhausted standard therapeutic options. The study will be conducted in 2 parts: dose escalation and dose expansion. The study is divided into 3 periods: a Screening Phase (within 28 days before the first dose of study drug), a Treatment Phase (first dose of study drug until the last dose of study drug) and a Post-treatment Follow-up Phase (up to the end of study participation or end of study). Participants' safety will be monitored throughout the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Participants will receive JNJ-63709178 in Part 1 and Part 2.
Unnamed facility
Detroit, Michigan, United States
Unnamed facility
New York, New York, United States
Unnamed facility
Charlotte, North Carolina, United States
Unnamed facility
Philadelphia, Pennsylvania, United States
Part 1: Number of participants with dose-limiting toxicity (DLT)
Time frame: Up to Day 28
Part 1: Type of dose-limiting toxicity (DLT)
Time frame: Up to Day 28
Part 2: Number of participants with adverse events and serious adverse events
Time frame: Up to 1.5 years
Part 2: Number of participants with adverse events by severity
Time frame: Up to 1.5 years
Part 2: Serum concentration of JNJ-63709178
Time frame: Up to 1.5 years
Part 2: JNJ-63709178 Receptor occupancy
Time frame: Up to 1.5 years
Part 2: Number of participants with depletion of CD123 expressing cells
Time frame: Up to 1.5 years
Part 2: Systemic cytokine concentration
Time frame: Up to 1.5 years
Part 2: Concentration of markers of T cell activation
Time frame: Up to 1.5 years
Part 2: Anti- JNJ-63709178 antibodies concentration
Time frame: Up to 1.5 years
Part 2: Overall response rate (ORR)
ORR rate is defined as the rate of complete response (CR) plus CR with incomplete recovery (CRi) plus CR with partial hematologic recovery (CRh).
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Unnamed facility
Pittsburgh, Pennsylvania, United States
Unnamed facility
Nashville, Tennessee, United States
Unnamed facility
Houston, Texas, United States
Unnamed facility
Barcelona, Spain
Unnamed facility
Madrid, Spain
Unnamed facility
Seville, Spain
Time frame: Up to 1.5 years
Part 2: Event-free survival (EFS)
EFS is defined as time from start of treatment to the date of an event, that is, first documented treatment failure, relapse from CR, CRi, or CRh, or death due to any cause.
Time frame: Up to 1.5 years
Part 2: Relapse-free survival (RFS)
RFS is defined as time from CR, CRi, or CRh confirmed objective response to relapse from CR, CRi, or CRh or death from any cause.
Time frame: Up to 1.5 years