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NCT05818683 · ClinicalTrials.gov registry record · Phase 1
A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer
A Phase 1 study of Metastatic Hormone-sensitive Prostate Cancer and Metastatic Castration-resistant Prostate Neoplasms, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 277
- Enrollment target
- 15
- Study locations
NCT05818683: Recruiting Phase 1 study of Metastatic Hormone-sensitive Prostate Cancer and Metastatic Castration-resistant Prostate Neoplasms, sponsored by Janssen Research & Development.
NCT05818683 is a Phase 1 study of Metastatic Hormone-sensitive Prostate Cancer and Metastatic Castration-resistant Prostate Neoplasms that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 277 participants, below the 648-participant average among 5 other Metastatic Hormone-sensitive Prostate Cancer trials with a reported enrollment target (57% lower). The trial reports 15 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05818683, a Phase 1 study of Metastatic Hormone-sensitive Prostate Cancer and Metastatic Castration-resistant Prostate Neoplasms, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 277 participants
- Enrollment target
- 15
- Study locations
Study Summary
The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of JNJ-78278343 and combination agent in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of JNJ-78278343 with the combination agent in Part 2 (dose expansion).
Primary Outcome
DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Apalutamide
- DRUG JNJ-78278343
- DRUG Cetrelimab
- DRUG Cabazitaxel
Study Locations (15)
Other
- Icon Cancer Centre Kurralta Park - Kurralta Park
- Macquarie University - Macquarie University
- Peter MacCallum Cancer Centre - Melbourne
- Princess Alexandra Hospital - Woolloongabba
- Hosp Univ Vall D Hebron - Barcelona
- Hosp Univ Fund Jimenez Diaz - Madrid
- Hosp. Univ. 12 de Octubre - Madrid
- Hosp Univ Hm Sanchinarro - Madrid
New York
- Perlmutter Cancer Center at NYU Langone Brooklyn - Brooklyn
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island - Mineola
- NYU Langone Health - New York
Florida
- Florida Cancer Specialists - Sarasota
Michigan
- Start Midwest - Grand Rapids
Missouri
- Washington University School Of Medicine - St Louis
Pennsylvania
- Sidney Kimmel Cancer Center - Jefferson Health - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 277 participants |
| Start Date | 2023-04-26 |
| Est. Completion | 2027-09-01 |
| Phase | Phase 1 |
What NCT05818683 shows while recruiting
NCT05818683 is an interventional study that assigns participants to a tested intervention. The registered 277 participants enrollment target is mid-sized for trials with a published cap, below the 648-participant average among 5 other Metastatic Hormone-sensitive Prostate Cancer trials with a reported enrollment target (57% lower).
The record links to 2 conditions, with Metastatic Hormone-sensitive Prostate Cancer appearing as the primary indexed condition, and to 5 interventions - of which Docetaxel is the first listed.
NCT05818683 lists 15 locations in 6 states (Other, New York, Florida).
Frequently Asked Questions
What is clinical trial NCT05818683 about?
NCT05818683 is a clinical study titled "A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer". The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of JNJ-78278343 and combination agent in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of JNJ-78278343 with the combination agent in Part 2 (dose expansion).
What is the current status of trial NCT05818683?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 277 participants. The study started on 2023-04-26. Estimated completion is 2027-09-01.
What conditions does trial NCT05818683 study?
This clinical trial studies the following conditions: Metastatic Hormone-sensitive Prostate Cancer, Metastatic Castration-resistant Prostate Neoplasms.
What interventions are being tested in trial NCT05818683?
The interventions under investigation include: Docetaxel (DRUG), Apalutamide (DRUG), JNJ-78278343 (DRUG), Cetrelimab (DRUG), Cabazitaxel (DRUG).
Who is sponsoring clinical trial NCT05818683?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05818683 being conducted?
This trial has 15 study locations across Florida, Michigan, Missouri, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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