Metastatic Castration-resistant Prostate Neoplasms
Conditions
Interventions
Experimental: Pasritamig Plus Best Supportive Care(BSC)
Participants will receive the step-up doses of pasritamig intravenously (IV) on Cycle 1 Day 1 (C1D1) and C1D8, and target dose of pasritamig IV
Sponsors
Fujikawa Ei
Eligibility
Sex/Gender
Male
Inclusion criteria
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 metastasis to visceral organs at the time of screening - 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: a. Cabazitaxel is not available b. 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: 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: a. PSMA-targeted lutetium radioligand therapy is unavailable, not accessible, or not clinically indicated. b. 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 (= 1.0 *10^9/per liter (L) E) Hemoglobin >= 8.0 grams per deciliter (g/dL) F) Platelet count >= 75 * 109/L
Exclusion criteria
Exclusion criteria: - Venous thromboembolic events within 1 month prior to the first dose of study treatment; uncomplicated (Grade 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Overall Survival (OS) OS is defined as the time from randomization to date of death due to any cause. [Time Frame: Up to 4 years and 8 months] | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Radiographic Progression-free Survival (rPFS) 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] v1.1 and prostate cancer working group 3 [PCWG3] criteria) or death, whichever comes first. [Time Frame: Up to 4 years and 8 months] 3. Time to Symptomatic Progression 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. [Time Frame: Up to 4 years and 8 months] 4. Time to Skeletal-Related Event 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 [Time Frame: Up to 4 years and 8 months] 5. Progression-Free Survival (PFS) 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. [Time Frame: Up to 4 years and 8 months] 6. Time to Prostate Specific Antigen (PSA) Progression 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 | — |
Countries
Australia, Japan, United States Of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed