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
juin 2028
07 juin 2026
The purpose of Parts 1, 2A, and 2B of the study is to determine the recommended regimen
for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 and the purpose of
Part 2C of this study is to determine how safe the RP2R(s) of the combination of
JNJ-87189401 and JNJ-78278343 is, with or without apalutamide. Part 3 of this study
evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with
standard of care (SOC) lutetium Lu-177 vipivotide tetraxetan. Part 4 of this study
further evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343
with JNJ-101556143 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, 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. 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