Actively Recruiting
A Phase 1b Study of Pasritamig (JNJ-78278343), a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-86974680, an A2a Receptor (A2aR) Antagonist, for Prostate Cancer
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
40
Participants Needed
5
Research Sites
16 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination of two drugs, Pasritamig and JNJ-86974680, for treating advanced prostate cancer. The study aims to find the recommended phase 2 combination dose (RP2CD) of these drugs in the first part and then assess the safety and tolerability of this dose in the second part. This phase 1b trial focuses on prostate cancer that has spread and is resistant to standard hormone therapy. Participants will receive Pasritamig intravenously and JNJ-86974680 orally. In Part 1, the study will identify the best dose combination by gradually adjusting doses to find the safest and most tolerable levels. Part 2 will use this recommended dose to further confirm safety and observe anti-tumor activity. Both parts involve close monitoring during and after treatment. Throughout the study, participants will be regularly assessed for side effects and how their cancer responds to treatment. This includes tracking adverse events, measuring prostate-specific antigen (PSA) levels, and evaluating tumor response using imaging. Blood samples will be taken to measure drug levels and check for immune responses. The study period for monitoring these outcomes can last up to 1 year and 2 months. Participants will be closely followed to understand the treatment's impact and safety.
CONDITIONS
Brief Title
A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 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
- Metastatic castration-resistant prostate cancer metastatic to bone or lymph nodes without clear visceral metastasis
- Prior orchiectomy or ongoing androgen deprivation therapy with GnRH analog before first study dose and continuing during treatment
- Prostate-specific antigen (PSA) level of 2 ng/mL or higher at screening
- Measurable or evaluable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You will not qualify if you...
- Toxicity from prior anticancer therapy not recovered to grade 1 or baseline except alopecia, grade 2 neuropathy, or vitiligo
- Known allergies or intolerance to components of pasritamig or JNJ-86974680
- Active infection requiring systemic antibiotics within 7 days before first study dose
- Presence of leptomeningeal disease or brain metastases except stable, treated brain metastases off corticosteroids for at least 2 weeks
- Serious medical conditions or issues impairing ability to receive treatment, understand consent, or follow protocol assessments
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 1 year 2 months
Participants receive pasritamig intravenously in combination with oral JNJ-86974680 to treat metastatic castration-resistant prostate cancer. The treatment includes a dose finding phase to determine the recommended dose followed by dose expansion to confirm safety and anti-tumor activity.
Regular visits for dosing and assessments during treatment period
Trial Site Locations
Total: 5 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
The Christie NHS Foundation Trust Christie Hospital
Manchester, United Kingdom, M20 4BX
Actively Recruiting
5
Royal Marsden Hospital
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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