2 results
Approved WMOCompleted
The primary endpoint is overall survival (OS) in patients with low hENT1 expression. Ifthe hENT1 expression data are available for analysis prior to randomizing 250 patientsthen an interim analysis for sample size re-estimation may be performed.
Approved WMOPending
Part 1 (Dose Escalation) - to identify the recommended Phase 2 dose(s) and schedule(s) to be safe for JNJ-79635322. Part 2 (Dose Expansion) is to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s).