NCT04644770

A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer

A Phase 1 Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Prostatic Neoplasms
• Adenocarcinoma

Interventions

Type	Name	Description
DRUG	JNJ-69086420	Participants will receive JNJ-69086420.
DRUG	JNJ-78278343	Participants will receive JNJ-78278343.
RADIATION	Stereotactic body radiation therapy	Participants will receive stereotactic body radiaition therapy.

Timeline

• Start date: 2020-11-12
• Primary completion: 2027-01-15
• Completion: 2027-01-15
• First posted: 2020-11-25
• Last updated: 2026-04-13

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study