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New treatment option for Prostatic Neoplasms
Official title A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate Cancer
ClinicalTrials.gov ID: NCT07319871
What this study is testing
What is Pasritamig?
Pasritamig is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for prostatic neoplasms.
Also referred to as JNJ-78278343.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed adenocarcinoma of the prostate. Primary small cell carcinoma, carcinoid tumor, neuroendocrine (NE) carcinoma, or large cell...
- Metastatic castration-resistant prostate cancer (mCRPC) that is metastatic either to bone, any lymph node, or both without clear evidence of...
- Prior orchiectomy or medical castration (for example, must be receiving ongoing androgen deprivation therapy with a gonadotropin-releasing hormone...
- Prostate-specific antigen (PSA) greater than or equal to (\>=) 2 nanograms per milliliters (ng/mL) at screening
- Measurable or evaluable disease
You likely 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...
- 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...
- Have leptomeningeal disease or brain metastases, except participants with definitively, locally treated brain metastases that are clinically stable...
- Any serious underlying medical conditions or other issue that would impair the ability of the participant to receive or tolerate the planned...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Sarasota, Florida, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Manchester, United Kingdom
- Sutton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sarasota, Florida, United States; New York, New York, United States; Cleveland, Ohio, United States; Manchester, United Kingdom; Sutton, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.