A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer
A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer
Sponsor: Janssen Research & Development, LLC
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT)
Time frame: Up to 21 days after first combination dose of study drugs
Number of Participants with Adverse Events (AEs) by Severity
Time frame: Up to 4 years 8 months
Secondary Endpoints
Serum Concentrations of JNJ-87189401 and JNJ-78278343
Plasma Concentration of JNJ-101556143
Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed * Measurable or evaluable disease per PCWG3 criteria * Part 1, Parts 2A, 2B, 3 and 4: Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist), prior to the first dose of study drug and must continue this therapy throughout the treatment phase * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: * History of an autoimmune disease within the 12 months prior to signing consent * Any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clin…
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