A Study of Pasritamig With or Without JNJ-87189401 Versus Placebo for Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)

NCT07164443
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
1,203
clinicaltrials.gov
Lead sponsor
Janssen Research & Development, LLC
clinicaltrials.gov
Start date
2025-09-02
clinicaltrials.gov
Number of sites
173
clinicaltrials.gov

Summary
The purpose of this study is to evaluate the overall survival (length of time from the start of study to date of death from any cause) for pasritamig (JNJ-78278343) in Part 1 in combination with best supportive care (BSC) and in Part 2 with JNJ-87189401+BSC as compared to placebo with BSC in participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of cancer that has spread beyond the prostate gland and is no longer responding to hormone therapies).
clinicaltrials.gov
Acronym
KLK2-comPAS
clinicaltrials.gov
Short title
A Study of Pasritamig With or Without JNJ-87189401 Versus Placebo for Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)
clinicaltrials.gov
Official title
A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T Cell Engaging Agent Targeting Human Kallikrein 2, With or Without JNJ-87189401, a PSMA-CD28 Costimulatory Agent, Plus Best Supportive Care Versus Best Supportive Care for Late-line Metastatic Castration-resistant Prostate Cancer
clinicaltrials.gov

Control arm
Placebo
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2028-08-18
clinicaltrials.gov
First posted
2025-09-10
clinicaltrials.gov
Registry last updated
2026-08-28
clinicaltrials.gov
Primary completion date
2028-08-18
clinicaltrials.gov
Start date
2025-09-02
clinicaltrials.gov

Participants
1,203
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
1,203
clinicaltrials.gov
Protocol amendments
4
clinicaltrials.gov
Number of sites
173
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Janssen Research & Development, LLC
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07164443
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07164443
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Overall Survival (OS)

    Timeframe: Up to 2 years and 8 months

    OS is defined as the time from randomization to date of death due to any cause.

  1. Radiographic Progression-free Survival (rPFS)

    Timeframe: Up to 2 years and 8 months

    rPFS assessed by investigator defined as the time from the date of randomization until the date of radiographic disease progression (based on response evaluation criteria in solid tumors \[RECIST\] version (v) 1.1 and prostate cancer working group 3 \[PCWG3\] criteria) or death, whichever comes first.

  2. Time to Symptomatic Progression

    Timeframe: Up to 2 years and 8 months

    Time to symptomatic progression is defined as time from the date of randomization to the date of any of the following (whichever occurs first): (a) the use of external beam radiation therapy to relieve cancer-related symptoms; (b) the need for tumor-related orthopedic surgical intervention; (c) other cancer-related procedures; (d) cancer-related morbid events; (e) initiation of a new systemic anti-cancer therapy because of cancer symptoms.

  3. Time to Skeletal-Related Event

    Timeframe: Up to 2 years and 8 months

    Time to skeletal-related event is defined as the time from the date of randomization to the date of first occurrence of any of the following (whichever occurs first): (a) the use of external beam radiation for skeletal or pelvic symptoms; b) the need for tumor-related orthopedic surgical intervention; (c) the occurrence of new bone fractures (cancer-related); (d) the occurrence of tumor-related spinal cord compression.

  4. Progression-Free Survival (PFS)

    Timeframe: Up to 2 years and 8 months

    PFS is defined as the date of randomization to the date of first evidence of radiographic progression, clinical progression, or death from any cause, whichever occurs first.

  5. Time to Prostate Specific Antigen (PSA) Progression

    Timeframe: Up to 2 years and 8 months

    Time to PSA progression, defined as the time from randomization to the first date of documented PSA progression per PCWG3 criteria. PSA progression is defined as: after a decline from baseline, PSA increases \>= 25 percentage (%) and \>= 2 nanograms per milliliter (ng/mL) above the nadir, confirmed by a second value \>= 3 weeks later (that is, a confirmed rising trend), or If there is no decline from baseline, PSA increases \>= 25 % and \>= 2 ng/mL from baseline after 12 weeks.

  6. Time to Pain Progression (TTPP) as Assessed by the Brief Pain Inventory-Short Form (BPI-SF) Item 3 Worst Pain in 24 Hours

    Timeframe: Up to 2 years and 8 months

    TTPP is defined as the time from the date of randomization to the date of the first observation of pain progression. Pain progression is defined as an increase of at least 2 points from baseline in the BPI-SF worst pain intensity (item 3) observed at 2 consecutive evaluations \>= 3 weeks apart. BPI-SF is an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score range from 0 to 10 with 0 representing "no pain" and 10 representing" pain as bad as you can imagine".

  7. Time to Deterioration in Fatigue as Assessed by the European Organisation For Research And Treatment of Cancer Quality of Life Questionnaire-Core-30 (EORTC QLQ-C30) Fatigue Scale Score

    Timeframe: Up to 2 years and 8 months

    Time to deterioration is defined as the time from randomization to the date of the first observation of deterioration in Fatigue. Deterioration in Fatigue is defined as an increase of 10 points on the EORTC QLQ-C30 FA scale observed at 2 consecutive evaluations \>= 3 weeks apart. The EORTC QLQ-C30 is a widely used tool for assessing the quality of life of cancer patients in clinical trials. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent". Each subscale of the EORTC QLQ-C30 is scored on a range from 0 to 100. Higher scores indicate worse symptoms or problems.

  8. Number of Participants with Adverse Events (AEs)

    Timeframe: Up to 2 years and 8 months

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

  9. Number of Participants with Abnormalities in Clinical Laboratory Assessments

    Timeframe: Up to 2 years and 8 months

    Participants with abnormalities in clinical laboratory parameters (hematology, clinical chemistry etc.) will be assessed.

Sources for outcomes
clinicaltrials.gov

Sex
Male
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Histologically confirmed adenocarcinoma of the prostate
  • Metastatic castration-resistant prostate cancer (mCRPC): Disease that is metastatic either to bone, any lymph node, or both without clear evidence of other metastatic sites at the time of screening by conventional imaging with computed tomography (CT) or magnetic resonance imaging (MRI) (chest, abdomen, and pelvis) and 99m^Tc bone scan. Visceral disease is not allowed
  • PSA greater than or equal to (≥) 2 nanogram per milliliter (ng/mL) at screening
  • In the opinion of the investigator, the next best treatment option is a clinical trial
  • Participants are required to have had all life-prolonging therapies for which they are clinically eligible in the opinion of the investigator and to which they have access. Prior therapies could have been given in any disease setting (not limited to mCRPC). In particular, prior treatment specifications include receipt of the following:

Androgen-receptor pathway inhibitor (ARPI): Must have progressed on at least 1 ARPI and unlikely to benefit from retreatment with another ARPI

Taxanes: Required to have received at least 2 previous taxane-based regimens. If a participant has received only 1 taxane regimen, the participant is eligible if:

  1. Cabazitaxel is not available
  2. The participant's physician deems the participant unsuitable to receive a second taxane regimen due to toxicity risk or prior intolerance Note: a taxane-based regimen consists of at least 2 cycles of a taxane (either as a single agent or in combination with other therapies) administered within the same 2-month period

Radioligand therapy: Required to have been previously treated with at least 1 dose of Prostate-specific membrane antigen (PSMA)-targeted lutetium radioligand therapy (eg, lutetium Lu-177 vipivotide tetraxetan), unless one of the following applies:

  1. PSMA-targeted lutetium radioligand therapy is unavailable, not accessible, or not clinically indicated.
  2. The participant's physician deems the participant unsuitable to receive PSMA-targeted lutetium radioligand therapy.

Polyadenosine diphosphate-ribose polymerase inhibitors (PARPi): Required to have been previously treated with PARPi, if the participant has a known germline or somatic BRCA mutation and treatment is available

  • Prior orchiectomy or medical castration (receiving ongoing ADT with a GnRH analog [agonist or antagonist]) prior to the first dose of study treatment and must continue this therapy throughout the treatment phase
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Participants are eligible if they have the following values:

A) eGFR ≥ 40 milliliters per minute (mL/min) B) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to (≤) 3 times the Upper Limit of Normal (ULN) C) Total bilirubin <1.5 times ULN D) Absolute neutrophil count (ANC) ≥ 1.0x10^9/per liter (L) E) Hemoglobin ≥ 8.0 grams per deciliter (g/dL) F) Platelet count ≥ 75x10^9/L

  • Venous thromboembolic events within 1 month prior to the first dose of study treatment; uncomplicated (Grade ≤ 2) deep vein thrombosis is not exclusionary
  • Active autoimmune disease within the past 12 months that requires systemic immunosuppressive medications (eg, chronic corticosteroid, methotrexate, or tacrolimus)
  • Participants with Grade 1 or higher fever (≥38ºC) or active infection requiring systemic treatment within 7 days prior to randomization are ineligible. Participants must be afebrile (<38ºC) at the time of study treatment dosing unless approved by medical monitor
  • Clinically significant pulmonary compromise, particularly a requirement for supplemental oxygen use (>2 liters per minute (L/min) by nasal cannula) to maintain adequate oxygenation
  • Prior or concurrent second malignancy (other than the disease under study) for which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)
  • Any of the following within 6 months prior to first dose of study treatment:

A) Myocardial infarction B) Severe or unstable angina C) Clinically significant ventricular arrhythmias D) Congestive heart failure (New York Heart Association class II to IV) E) Transient ischemic attack F) Cerebrovascular accident

- Prior treatment with any CD3-directed therapy

Sources for eligibility
clinicaltrials.gov

  • University of California at San DiegoLa Jolla, United StatesRecruiting
  • Cedars Sinai Medical CenterLos Angeles, United StatesRecruiting
  • Ronald Reagan UCLA Medical CenterLos Angeles, United StatesRecruiting
  • San Francisco VA Medical CenterSan Francisco, United StatesRecruiting
  • Rocky Mountain Cancer CentersAurora, United StatesRecruiting
  • University of Colorado Cancer CenterAurora, United StatesRecruiting
  • Colorado Clinical ResearchLakewood, United StatesRecruiting
  • Hartford HospitalHartford, United StatesRecruiting
  • Johns Hopkins Office of Capital Region Research - Sibley Memorial HospitalWashington D.C., United StatesRecruiting
  • Bay Pines VA Healthcare SystemBay Pines, United StatesRecruiting
  • Florida Cancer Specialists & Research InstituteFort Myers, United StatesRecruiting
  • Moffitt Cancer CenterTampa, United StatesRecruiting
  • University of Iowa Hospital and ClinicsIowa City, United StatesRecruiting
  • Mission Cancer BloodWaukee, United StatesRecruiting
  • East Jefferson General HospitalMetairie, United StatesRecruiting
  • Johns Hopkins UniversityBaltimore, United StatesRecruiting
  • Dana Farber Cancer InstituteBoston, United StatesRecruiting
  • University of Michigan Health SystemAnn Arbor, United StatesRecruiting
  • Henry Ford Cancer DetroitDetroit, United StatesRecruiting
  • University Of Minnesota Medical CenterMinneapolis, United StatesRecruiting
  • XCancer Omaha / Urology Cancer CenterOmaha, United StatesRecruiting
  • NYU Langone HospitalsBrooklyn, United StatesRecruiting
  • NYU Langone Hospital Long IslandMineola, United StatesRecruiting
  • NYU Langone Health Laura and Isaac Perlmutter Cancer CenterNew York, United StatesRecruiting
  • Columbia University Medical CenterNew York, United StatesRecruiting

And 148 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-520927-26-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)