Back to search
A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer
Adenocarcinoma
Prostatic Neoplasms
Clinicaltrials.gov:
J&J ID:
#CR108817
Other:
#69086420PCR1001
Subscribe or share this trial
Trials at a glance
Status
Enrollment complete
Condition
Adenocarcinoma
Prostatic Neoplasms
Trial type
Interventional
Trial phase
Phase 1
Investigational
product
product
JNJ-69086420
JNJ-78278343
Stereotactic body radiation therapy
Age
18+ years old
Biological sex
Male
Placebo?
No
Trial start date
November 12, 2020
Trial end date
December 30, 2026
CT.gov ID
#NCT04644770
A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) of JNJ-69086420 in Part 1 (Dose Escalation), to determine safety and preliminary signs of clinical activity at the RP2D(s) in Part 2 (Dose Expansion), to determine safety of JNJ-69086420 at the RP2D(s) as a combination therapy in Part 3 (combination therapy) and to determine safety of JNJ-69086420 at the RP2D(s) in participants with metastatic hormone-sensitive prostate cancer (mHSPC) in Part 4.
Primary outcome measures
- Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
- Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
- Number of Participants with AEs by Severity
Secondary outcome measures
- Percentage of Participants with Prostate Specific Antigen (PSA) Response
- Overall Response Rate (ORR)
- Maximum Observed Serum Concentration/Radioactivity (Cmax) of JNJ-69086420
- Time to Reach Maximum Observed Serum Concentration/Radioactivity (Tmax) of JNJ-69086420
- Area Under the Serum Concentration-time Curve From Time Zero to t Time (AUC[0-t]) of JNJ-69086420
- Number of Participants With Anti-JNJ-69086420 Antibodies
- Part 3: Serum Concentration of JNJ-78278343
- Part 3:Number of Participants With Anti-JNJ-78278343 Antibodies
Access detailed information on the trial:
Clinical trials information
Key links
© Johnson & Johnson and its affiliates 2026
