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
19 juillet 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 | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Leon Berard - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
Critères
Homme
Inclusion Criteria:
- Metastatic castration-resistant prostate cancer (mCRPC) as defined by Prostate
Cancer Working Group 3 (PCWG3): 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; all participants must have a
serum PSA value greater than or equal to (>=2) nanograms per milliliter (ng/mL) at
time of screening
- 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
- Metastatic castration-resistant prostate cancer (mCRPC) as defined by Prostate
Cancer Working Group 3 (PCWG3): 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; all participants must have a
serum PSA value greater than or equal to (>=2) nanograms per milliliter (ng/mL) at
time of screening
- 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
- 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