Pasritamig
BiologicalPasritamig will be administrated through IV infusion.
Other names: JNJ-78278343
NCT Number: NCT07164443
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).
Interested in participating?
Request Info18 year and older
Male
Interventional
Phase 3
Warringal Private Hospital, Heidelberg, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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:
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:
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
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
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
Pasritamig will be administrated through IV infusion.
Other names: JNJ-78278343
Placebo will be administrated through IV infusion.
BSC will be administered at the discretion of the treating physician.
Time frame: Up to 2 years and 8 months
OS is defined as the time from randomization to date of death due to any cause.
Time frame: 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] v1.1 and prostate cancer working group 3 [PCWG3] criteria) or death, whichever comes first.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: Up to 2 years and 8 months
Participants with abnormalities in clinical laboratory parameters (hematology, clinical chemistry etc.) will be assessed.
Contact information is provided by the study sponsor or research team.
Janssen Research & Development, LLC
Industry
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
Acronym: KLK2-comPAS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05818683
Metastatic Castration-resistant Prostate Neoplasms, Metastatic Hormone-sensitive Prostate Cancer
Sarasota, Florida, United States
View Trial Details