Informations générales (source: ClinicalTrials.gov)
A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer
Interventional
Phase 1
Janssen Research & Development, LLC (Voir sur ClinicalTrials)
novembre 2023
octobre 2027
02 novembre 2025
The purpose of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of
combination of JNJ-87189401 with JNJ-78278343 (Part 1: dose escalation) and further
evaluate the safety at RP2Rs (Part 2: dose expansion) in participants with advanced
prostate cancer.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Capucine BALDINI | 20/06/2024 08:22:49 | Contacter | ||
Critères
Homme
- 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, Part 2A and Part 2B: 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:
- Active autoimmune disease within the 12 months prior to signing consent that
requires systemic immunosuppressive medications (example, chronic corticosteroids,
methotrexate, or tacrolimus)
- Any of the following within 6 months prior to signature of informed consent: a.
myocardial infarction, b. severe or unstable angina, c. clinically significant
ventricular arrhythmias, d. congestive heart failure (New York Heart Association
[NYHA] class II to IV), e. transient ischemic attack, and f. Cerebrovascular
accident