A Phase III 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
Study Identifier:
78278343PCR3001
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
Recruiting
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Study 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 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).
To evaluate overall survival (defined as the time from study initiation to death from any cause) in the metastatic castration-resistant prostate cancer (mCRPC) population using Pastritamig (JNJ-78278343) plus best supportive care (BSC) versus placebo plus BSC.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
III
Sex
Male
Age
18+ years
Study Drug
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
Inclusion criteria
- Histologically confirmed adenocarcinoma of the prostateMetastatic 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 scanPSA greater than or equal to (>=) 2 nanogram per milliliter (ng/mL) at screeningIn the opinion of the investigator, the next best treatment option is a clinical trialParticipants 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:
- Cabazitaxel is not availableThe 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 treatmentRadioligand 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:
- PSMA-targeted lutetium radioligand therapy is unavailable, not accessible, or not clinically indicated.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 phaseEastern Cooperative Oncology Group (ECOG) performance status of 0 to 2Participants 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 exclusionaryActive 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 monitorClinically significant pulmonary compromise, particularly a requirement for supplemental oxygen use (>2 liters per minute (L/min) by nasal cannula) to maintain adequate oxygenationPrior 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
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Carolinas
Myrtle Beach, SC, United States, 29572
Investigator
Neal Shore
Status
Recruiting
Condition(s) Treated at Site
Prostate