Actively Recruiting
A Study of JNJ-78278343 in Combination With JNJ-95298177 for Treatment of Prostate Cancer
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
140
Participants Needed
6
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of JNJ-78278343 in Combination With JNJ-95298177 for Treatment of Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the prostate; adenocarcinomas with neuroendocrine features allowed
- Must have metastatic castration-resistant prostate cancer (mCRPC)
- PSA must measure at least 2 nanograms per milliliter at screening
- Measurable or evaluable disease
- Prior orchiectomy or medical castration; or receiving ongoing androgen deprivation therapy with a gonadotropin-releasing hormone analog
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You will not qualify if you...
- Toxicity from prior anticancer therapy not resolved to grade 1 or baseline (except hair loss and vitiligo)
- Known allergies or intolerance to components of JNJ-78278343 or JNJ-95298177
- Leptomeningeal disease or brain metastases except stable, asymptomatic, locally treated brain metastases off corticosteroids for at least 2 weeks
- Treatment with any anticancer or investigational agents within 14 days prior to study treatment; specific restrictions include:
- T-cell redirecting therapies within 90 days
- Immune checkpoint inhibitors within 6 weeks
- Radium 223 dichloride within 28 days
- Prior KLK2-targeted therapy
- Prior PSMA-targeting therapy (Parts 2A and 2B only)
- Prior antibody drug conjugates with microtubule inhibitor payloads
- Serious medical conditions or other issues preventing treatment or informed consent, or interfering with study assessments
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
2
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
3
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
4
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
5
The Christie Nhs Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
6
Royal Marsden Hospital (Sutton)
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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