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New treatment option for Prostatic Neoplasms
Official title A Study of JNJ-78278343 in Combination With JNJ-95298177 for Treatment of Prostate Cancer
ClinicalTrials.gov ID: NCT07082920
What this study is testing
What is JNJ-78278343?
JNJ-78278343 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for prostatic neoplasms.
Also referred to as Pasritamig.
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 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.
- 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, men only
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...
- Must have metastatic castration-resistant prostate cancer (mCRPC)
- PSA must measure at least 2 nanograms per milliliters (ng/mL) at screening
- Measurable or evaluable disease
- Prior orchiectomy or medical castration; or, for participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation...
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 and...
- Known allergies, hypersensitivity, or intolerance to any of the components (e.g., excipients) of JNJ-78278343 or JNJ-95298177
- Participants with leptomeningeal disease or brain metastases, with the exception of participants with definitively, locally treated brain metastases...
- Treatment with any anti-cancer or investigational agents within 14 days prior to the first dose of study treatment; specific requirements for certain...
- Any T-cell redirecting treatment (e.g., CD3-directed bispecific or Chimeric Antigen Receptor T-cell [CAR-T] therapy) within 90 days prior to the...
- Immune checkpoint inhibitors within 6 weeks prior to the first dose of study treatment
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...
- Must have metastatic castration-resistant prostate cancer (mCRPC)
- PSA must measure at least 2 nanograms per milliliters (ng/mL) at screening
- Measurable or evaluable disease
- Prior orchiectomy or medical castration; or, for participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analog (agonist or...
- 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 and vitiligo)
- Known allergies, hypersensitivity, or intolerance to any of the components (e.g., excipients) of JNJ-78278343 or JNJ-95298177
- Participants with leptomeningeal disease or brain metastases, with the exception of participants with definitively, locally treated brain metastases that are clinically stable and asymptomatic greater than (\>) 2 weeks...
- Treatment with any anti-cancer or investigational agents within 14 days prior to the first dose of study treatment; specific requirements for certain anti-cancer therapies are as follows:
- Any T-cell redirecting treatment (e.g., CD3-directed bispecific or Chimeric Antigen Receptor T-cell [CAR-T] therapy) within 90 days prior to the first dose of study treatment
- Immune checkpoint inhibitors within 6 weeks prior to the first dose of study treatment
- Radium (Ra) 223 dichloride within 28 days prior to the first dose of study treatment
- Any prior treatment with kallikrein-related peptidase 2 (KLK2)-targeted therapy
- Any prior prostate-specific membrane antigen (PSMA)-targeting therapy (that is [i.e.], participants who received PSMA-targeting radioconjugates are excluded) [Parts 2A and 2B only]. Prior PSMA RLT is allowed in Part 1...
- Any prior antibody drug conjugates (ADCs) with microtubule inhibitor payloads (e.g., auristatins, maytansinoids, tubulysins)
- 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
- Seattle, Washington, 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 male, 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; Seattle, Washington, 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.