Trials / Recruiting
RecruitingNCT07082920
A Study of JNJ-78278343 in Combination With JNJ-95298177 for Treatment of Prostate Cancer
A Phase 1b Study of JNJ-78278343, a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-95298177, an Antibody Drug Conjugate Targeting Prostate Specific Membrane Antigen, for Prostate Cancer
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of JNJ-78278343 in combination with JNJ-95298177 in Part 1 (Dose confirmation) of the study and to determine how safe and tolerable the RP2CD is for treatment of participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of prostate cancer where the cancer has spread beyond the prostate and is resistant to hormonal therapy) in Part 2 (Dose expansion) of study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JNJ-78278343 | JNJ-78278343 will be administered intravenously. |
| DRUG | JNJ-95298177 | JNJ-95298177 will be administered intravenously. |
Timeline
- Start date
- 2025-07-07
- Primary completion
- 2027-01-28
- Completion
- 2027-03-01
- First posted
- 2025-07-24
- Last updated
- 2026-04-13
Locations
6 sites across 2 countries: United States, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07082920. Inclusion in this directory is not an endorsement.