What this study is
The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of Pasritamig in combination with JNJ-86974680 in Part 1 (Dose finding) of the study and to determine how safe and tolerable the RP2CD is for treatment of participants with advanced prostate cancer in Part 2 (Dose expansion) of study.
What's being tested
- Pasritamig
Intervention · DRUG
Pasritamig will be administered intravenously.
- JNJ-86974680
Intervention · DRUG
JNJ-86974680 will be administered orally.
Study details
- Official title
- 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
- Sponsor
- Janssen Research & Development, LLC
- Conditions
- Prostatic Neoplasms
- Enrolling
- 40 people
- Starts
- 2026-01-14
- Est. completion
- 2028-03-15
- Design
- Open-label, non-randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Histologically confirmed adenocarcinoma of the prostate. Primary small cell carcinoma, carcinoid tumor, neuroendocrine (NE) carcinoma, or large cell NE carcinoma arising in the prostate are not allowed; however, adenocarcinomas with NE features (for example [e.g.], immunohistochemistry [IHC] with both androgen receptor [AR]- and NE-marker positivity) are allowed
- Metastatic castration-resistant prostate cancer (mCRPC) that is metastatic either to bone, any lymph node, or both without clear evidence of metastasis to visceral organs. Local-regional invasion (rectum, bladder) and bone disease with soft tissue component can be included
- Prior orchiectomy or medical castration (for example, must be receiving ongoing androgen deprivation therapy with a gonadotropin-releasing hormone [GnRH] analog [agonist or antagonist] prior to the first dose of study drug and must continue this therapy throughout the treatment phase)
- Prostate-specific antigen (PSA) greater than or equal to (>=) 2 nanograms per milliliters (ng/mL) at screening
- Measurable or evaluable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You can't join if
- Toxicity related to prior anticancer therapy that has not returned to grade less than or equal to (<=) 1 or baseline levels (except for alopecia, neuropathy [Grade 2] and vitiligo)
- Known allergies, hypersensitivity, or intolerance to any of the components (for example, excipients) of pasritamig or JNJ-86974680
- Active infection or condition that requires treatment with systemic antibiotics within 7 days prior to the first dose of study treatment. Antibiotic or antiviral prophylaxis is allowed
- Have leptomeningeal disease or brain metastases, except participants with definitively, locally treated brain metastases that are clinically stable and asymptomatic >2 weeks, and who are off corticosteroid treatment for at least 2 weeks prior to first dose of study treatment
- Any serious underlying medical conditions or other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site to understand the informed consent, or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (5)
5 openFlorida Cancer Specialists
Sarasota, Florida, United States
RecruitingColumbia University Medical Center
New York, New York, United States
RecruitingUniversity Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Recruiting
2 sites outside the US
The Christie NHS Foundation Trust Christie Hospital
Manchester, United Kingdom
RecruitingRoyal Marsden Hospital
Sutton, United Kingdom
Recruiting
Study team
Sponsor
Janssen Research & Development, LLC
Study ID 78278343PBPCR1005
Study director
Janssen Research & Development, LLC Clinical trial
Janssen Research & Development, LLC
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.