Informations générales (source: ClinicalTrials.gov)
A Phase 1 Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer
Interventional
Phase 1
Janssen Research & Development, LLC (Voir sur ClinicalTrials)
juillet 2021
février 2026
19 juillet 2025
The purpose of this study is to determine the recommended phase 2 dose(s) (RP2Ds) of
JNJ-78278343 in Part 1 (Dose Escalation) and the safety at the RP2Ds in Part 2 (Dose
Expansion).
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 08:36:23 | 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 | |||||
| APHM Hopital Timone - 13005 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Centre Leon Berard - 69373 - Lyon Cedex 8 - France | Contact (sur clinicalTrials) | ||||
Critères
Homme
Inclusion Criteria:
- Confirmed adenocarcinoma of the prostate which has spread to other body parts
- Part 1: Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted
therapy or chemotherapy
- Measurable or evaluable disease
- Concurrent use of any other anticancer treatment must be discontinued for at least 2
weeks before the first dose of study drug
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Prior surgical removal of testicles; or, for participants who have not undergone
surgical removal of testicles, must be receiving ongoing androgen deprivation
therapy (ADT) with a gonadotropin releasing hormone analog
- Confirmed adenocarcinoma of the prostate which has spread to other body parts
- Part 1: Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted
therapy or chemotherapy
- Measurable or evaluable disease
- Concurrent use of any other anticancer treatment must be discontinued for at least 2
weeks before the first dose of study drug
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Prior surgical removal of testicles; or, for participants who have not undergone
surgical removal of testicles, must be receiving ongoing androgen deprivation
therapy (ADT) with a gonadotropin releasing hormone analog
Disease conditions
- Active central nervous system (CNS) involvement
- Toxicity related to prior anticancer therapy has not adequately recovered
Prior/Concomitant Therapy
- Prior treatment with human kallikrein (KLK) 2-targeted therapy
- Received, or are receiving, medications that suppress the immune system within 3
days prior to the first dose of study drug
- Received or plans to receive any live, attenuated vaccine within 4 weeks prior to
the first dose of study drug
Prior/Concurrent Medical Conditions
- Diagnosis of cancer other than prostate cancer within 2 years prior to the first
dose of study drug
- Solid organ or bone marrow transplantation
- Major clotting diseases within one month prior to the first dose of study drug
- Active autoimmune disease within 12 months prior to the first dose of study drug
- Active infection
- Major diseases of heart and blood vessels within 6 months prior to the first dose of
study drug
- Clinically significant lung diseases
- Active or chronic hepatitis B or hepatitis C infection
- Known positive test result for human immunodeficiency virus (unless stable on
antiretroviral therapy with undetectable viral load)
- Any serious underlying medical conditions or other issue that would impair the
ability of the participant to receive or tolerate the planned treatment