Informations générales (source: ClinicalTrials.gov)
A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T Cell Redirecting Agent Targeting Human Kallikrein 2, + Best Supportive Care Versus Best Supportive Care for Metastatic Castration-resistant Prostate Cancer
Interventional
Phase 3
Janssen Research & Development, LLC (Voir sur ClinicalTrials)
septembre 2025
mai 2028
12 mai 2026
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
combination with best supportive care (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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Ronan FLIPPOT | 12/05/2026 13:40:07 | Contacter | ||
Critères
Homme
Inclusion Criteria
- 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
- 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 should 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: Should 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.
Participants who cannot continue taxane therapy because of a documented Grade>=3
taxane related IRR are eligible for enrollment, even if they received fewer than 2
prior cycles of taxane treatment
Radioligand therapy: Should 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): Should 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 >= 30 milliliters per minute (mL/min) B) Alanine Aminotransferase (ALT) and
Aspartate Aminotransferase (AST) less than or equal to (<=) 5 times the Upper Limit of
Normal (ULN) C) Serum total bilirubin <= 3 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
Exclusion Criteria
- 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
- 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
- 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 should 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: Should 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.
Participants who cannot continue taxane therapy because of a documented Grade>=3
taxane related IRR are eligible for enrollment, even if they received fewer than 2
prior cycles of taxane treatment
Radioligand therapy: Should 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): Should 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 >= 30 milliliters per minute (mL/min) B) Alanine Aminotransferase (ALT) and
Aspartate Aminotransferase (AST) less than or equal to (<=) 5 times the Upper Limit of
Normal (ULN) C) Serum total bilirubin <= 3 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
Exclusion Criteria
- 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