N=~155
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Key eligibility criteria*:
- Part 1 and 2: Diagnosed with AML or high-risk MDS
- Part 3: Diagnosed with AML
- Part 4: Diagnosed with previously untreated AML
- ECOG PS 0–2
- No prior or concurrent secondary malignancies
- No medical history of clinically significant pulmonary compromise
- No active CNS involvement
Primary outcomes:
- DLTs
- AEs
Secondary outcomes:
- Serum concentration of JNJ-90189892
- ADAs
- PK
- Overall response in MDS
- CR
- TTR
- DOR
- Transfusion independence
- Part 4: OS, EFS
*Not a complete list of inclusion and exclusion criteria. †Participants with relapsed or refractory AML or MDS in Part 1 (dose escalation) and Part 2 (dose expansion). ‡Participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) in Part 3 will receive JNJ-90189892 + azacitadine + venetoclax to determine the recommended Phase 2 combination dose (RP2CD). The starting JNJ-90189892 dose regimen in Part 3 will be at least 1 dose level below the highest dose level cleared in Part 1. In Part 4 participants with newly diagnosed AML will receive JNJ-90189892+ azacitadine + venetoclax starting from the JNJ-90189892 dose level determined safe in Part 3.
ADA, antidrug antibody; AE, adverse event; AML, acute myeloid leukemia; CNS, central nervous system; CR, complete response; DLT, dose-limiting toxicity; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EFS, event-free survival; MDS, myelodysplastic neoplasms; PK, pharmacokinetics; TTR, time to response.