Actively Recruiting
Study of JNJ-78278343 Combined With JNJ-95298177 for Metastatic Castration-Resistant Prostate Cancer Treatment
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
140
Participants Needed
6
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the combination of two investigational drugs, JNJ-78278343 and JNJ-95298177, to find the recommended phase 2 dose and evaluate its safety and tolerability for treating metastatic castration-resistant prostate cancer (mCRPC), a type of prostate cancer that has spread and no longer responds to hormonal therapy. This phase 1b study focuses on patients with advanced prostate cancer resistant to standard treatments. Participants will receive both drugs intravenously. In Part 1, a dose de-escalation approach using a specific design helps determine the recommended phase 2 combination dose (RP2CD). In Part 2, participants receive the RP2CD to confirm safety and assess anti-tumor activity. The study does not use randomization or blinding. During the study, researchers will monitor for side effects and dose-limiting toxicities up to about two years and two months. They will assess responses through various measures including PSA levels, imaging, and serum drug concentrations. Participants will have regular evaluations to track safety, treatment effects, and the presence of antibodies against the study drugs. The total study duration includes follow-up for these outcomes.
CONDITIONS
Brief 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, excluding primary small cell carcinoma, carcinoid tumor, neuroendocrine carcinoma, or large cell neuroendocrine carcinoma; adenocarcinomas with neuroendocrine features are allowed
- Diagnosed with metastatic castration-resistant prostate cancer (mCRPC)
- PSA level of at least 2 nanograms per milliliter at screening
- Measurable or evaluable disease
- Prior orchiectomy or ongoing androgen deprivation therapy with a gonadotropin-releasing hormone analog before first study drug dose and continuing through treatment phase
- 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 alopecia and vitiligo
- Known allergies or intolerance to components of JNJ-78278343 or JNJ-95298177
- Leptomeningeal disease or brain metastases, except locally treated, stable, asymptomatic brain metastases off corticosteroids for more than 2 weeks
- Treatment with other anticancer or investigational agents within 14 days prior to first study dose, including:
- T-cell redirecting therapies within 90 days
- Immune checkpoint inhibitors within 6 weeks
- Radium 223 dichloride within 28 days
- Prior KLK2-targeted therapies
- Prior PSMA-targeting therapies (with exceptions for Part 1 and certain Part 2 cohorts)
- Prior antibody-drug conjugates with microtubule inhibitor payloads
- Serious underlying medical conditions or other issues impairing ability to receive or tolerate treatment or understand informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years and 2 months
Participants receive JNJ-78278343 in combination with JNJ-95298177 administered intravenously to treat metastatic castration-resistant prostate cancer. Treatment includes a dose confirmation phase and a dose expansion phase to determine and confirm the recommended phase 2 combination dose and assess safety and anti-tumor activity.
Repeated infusion visits as per dosing schedule
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
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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