Advanced Prostate Cancer
To determine the recommended Phase 2 regimen(s) (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 NCT06095089
A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined with JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer.
– Histologically confirmed adenocarcinoma of the prostate
– Measurable or evaluable disease per PCWG3 criteria
– Can have a prior or concurrent second malignancy (other than the disease under study) whose natural history or treatment is unlikely to interfere with any study endpoints of safety or efficacy
– Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
– History of solid organ or bone marrow transplantation.
– Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications
– Active infection or condition that requires treatment with systemic antibiotics within 7 days prior to the first dose of study drug. Antibiotic or antiviral prophylaxis is allowed.
– Any of the following within 6 months prior to signature of informed consent:
Myocardial infarction
Severe or unstable angina
Clinically significant ventricular arrhythmias
Congestive heart failure
Transient ischemic attack
Cerebrovascular accident
Known malignant central nervous system (CNS) or leptomeningeal disease
Active hepatitis of infectious origin.
Concurrent use of any anticancer treatment other than ADT or investigational agent within 2 weeks before the planned first dose of study treatment.
To register your interest or find out more information about this clinical trial, please email: enquiries@gallipoliresearch.org.au.
Gallipoli Medical Research, Greenslopes Private Hospital, Brisbane
