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NCT07746713

A Study of JNJ-98768111 in Participants With Advanced Prostate Cancer

StatusRecruiting
PhasePhase 1
Primary completion (estimated)
Track this trial

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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Enrollment increased: 100 → 160 participants
    • Study sites: 5 to 6
  2. Study sites: 3 to 5
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 2 of 10 entries
  3. Recruitment opened
    • Trial sites expanded: 0 → 3 locations
    • Start date changed from estimate of Aug 17, 2026 to Aug 5, 2026
    • Eligibility criteria expanded, about 69 words
    v2
  4. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of Participants with Adverse Events (AEs)
Timeframe: Up to approximately 2 years 7 months
Part 1: Number of Participants with Dose-Limiting Toxicities (DLT)
Timeframe: From first administration of trial intervention to the pre-dose assessment of the second cycle (up to approximately 2 years and 7 months)

Secondary (10)

Maximum Observed Concentration (Cmax) of JNJ-98768111
Trough Concentration (Ctrough) of JNJ-98768111
Time to Maximum Observed Concentration (Tmax) of JNJ-98768111
Area Under the Concentration-Time Curve from Time 0 to End of Dosing Interval (AUC [0-tau]) of JNJ-98768111
Accumulation Ratio of JNJ-98768111
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Number of Participants With Anti-Drug Antibodies (ADAs) to JNJ-98768111
Objective Response Rate (ORR)
Radiographic Progression-Free Survival (rPFS)
Prostate-Specific Antigen (PSA) Response
Duration of Response (DOR)

Arms and interventions

JNJ-98768111Experimental

Participants in Part 1 of the study will receive escalating doses of JNJ-98768111 to identify the putative recommended phase 2 dose (pRP2D) regimen(s). Participants in Part 2 of the study will receive JNJ-98768111 at the pRP2D regimen(s) determined in Part 1.

Drugs: JNJ-98768111

Sites

6 sites in 2 countries

United States 4, Israel 2