Pasritamig + Docetaxel for Prostate Cancer
(KLK2-PASenger Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a new treatment combination of pasritamig (an experimental treatment) and docetaxel (a chemotherapy drug) can delay the progression of metastatic castrate-resistant prostate cancer, which continues to grow even when male hormones are very low. The study compares this new combination to the current treatment with only docetaxel. Men with prostate cancer that has spread and progressed despite previous hormone treatments might be eligible. Participants should not have cancer that has spread to the brain or certain genetic mutations like BRCA, and they must have previously discontinued any androgen receptor pathway inhibitors, a type of hormone therapy. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a treatment that could soon become widely available.
Will I have to stop taking my current medications?
The trial requires that you continue taking androgen deprivation therapy (ADT) throughout the treatment. You must stop any androgen receptor pathway inhibitors (ARPI) before joining the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining pasritamig with docetaxel appears safe for individuals with advanced prostate cancer. One study found that 42% of patients experienced a significant drop in PSA levels, which help monitor prostate cancer. This treatment combination is generally well-tolerated, though, like many cancer treatments, it can cause side effects. Common side effects include mild to moderate fatigue and nausea. More serious side effects are less common but can occur. Participants must be closely monitored by their healthcare team during the trial to manage any side effects effectively.12345
Why do researchers think this study treatment might be promising for prostate cancer?
Researchers are excited about Pasritamig for prostate cancer because it targets the condition differently from current therapies. Unlike standard treatments that mainly focus on hormone pathways or chemotherapy alone, Pasritamig is a novel agent that works alongside docetaxel to enhance the treatment's effectiveness. This combination approach aims to provide a more powerful attack on cancer cells, potentially leading to improved outcomes for patients. Additionally, by integrating Pasritamig with established chemotherapy, researchers hope to overcome resistance seen in traditional therapies, offering new hope for those with advanced prostate cancer.
What evidence suggests that pasritamig + docetaxel might be an effective treatment for prostate cancer?
Research shows that combining pasritamig with docetaxel may effectively treat advanced prostate cancer that no longer responds to hormone therapy. In this trial, one group of participants will receive pasritamig with docetaxel. Studies have found that patients taking pasritamig experienced significant drops in prostate-specific antigen (PSA) levels, which monitor cancer progression. In a specific group of patients, the average time before the cancer worsened, known as radiographic progression-free survival (rPFS), was about 7.85 months. This suggests that pasritamig, when used with docetaxel, might help slow the cancer's progression. Overall, pasritamig is generally well-tolerated and shows promising anti-cancer effects.12367
Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
This trial is for men with advanced prostate cancer that has spread and continues to grow despite low hormone levels. Participants must be on hormone therapy or have had surgery to lower hormones, and their cancer should not have worsened after up to two different treatments targeting the androgen receptor.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pasritamig along with docetaxel until the end of trial visit or until confirmed radiographic progression
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for overall survival and other secondary outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Docetaxel
- Pasritamig
Trial Overview
The study is testing if a combination of Pasritamig and Docetaxel can extend the time before prostate cancer gets worse compared to just using Docetaxel. Patients will receive either the combo or only Docetaxel, determined by chance.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive pasritamig along with docetaxel until the end of trial (EOT) visit or until confirmed radiographic progression by blinded independent central review (BICR), or any other protocol defined criteria are met.
Participants will receive docetaxel along with prednisone as background medication.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University
Citations
NCT07225946 | A Study of Pasritamig With Docetaxel ...
The purpose of this study is to find out whether treatment with pasritamig and docetaxel prolongs radiographic progression free survival (rPFS) ...
Pasritamig, a First-in-Class, Bispecific T-Cell Engager ...
In the RP2D efficacy population (n = 33), median radiographic progression-free survival was 7.85 (95% CI, 2.89 to not estimable) months, and 14 ...
3.
jnjmedicalconnect.com
jnjmedicalconnect.com/media/attestation/congresses/oncology/2025/am/phase-1-study-results-of-jnj78278343-pasritamig-in-metastatic-castrationresistant-prostate-cancer-mc.pdfPhase 1 Study Results of Pasritamig (JNJ-78278343) in ...
metastatic prostate cancer. N Engl J Med 2019;381(26):2506-2518. CRS ... Pasritamig Achieved Rapid and Deep Prostate-Specific Antigen Responses.
Metastatic prostate cancer: Clinical trials to watch
Patients will be randomized to continue. ADT with ARPI alone versus the addition of docetaxel (75 mg/m2 IV every 3 weeks for up to 6 cycles).
Pasritamig, a first-in-class bispecific ...
Pasritamig appears well-tolerated and exhibits a promising antitumor activity in patients with metastatic castration-resistant prostate cancer (mCRPC).
6.
onclive.com
onclive.com/view/pasritamig-displays-safety-durable-disease-control-in-heavily-pretreated-mcrpcPasritamig Displays Safety, Durable Disease Control in ...
Pasritamig showed promising efficacy in mCRPC, with 42.4% achieving a 50% PSA reduction and an 8.3% overall response rate. · The median duration ...
Pasritamig Safety and Efficacy Data from Metastatic CRPC ...
Despite being a phase I trial, efficacy was impressive with 42% of patients achieving PSA50 responses and median radiographic progression-free ...
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