Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04898634
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2021-05-20
Brief Title:
A Study of JNJ-78278343 a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 KLK2 for Advanced Prostate Cancer
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Phase 1 Study of JNJ-78278343 a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 KLK2 for Advanced Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the recommended phase 2 doses RP2Ds of JNJ-78278343 in Part 1 Dose Escalation and the safety at the RP2Ds in Part 2 Dose Expansion
Detailed Description:
JNJ-78278343 is a humanized immunoglobulin IgG1-based bispecific antibody designed to direct T lymphocytes T cells to human kallikrein 2 hK2or KLK2 positive target tumor cells One arm of JNJ-78278343 binds to the cluster of differentiation CD3 receptor complex present on T cells and the other arm binds to KLK2 present on target tumor cells leading to the activation of the T cells and T-cell-mediated lysis of the KLK2 bearing tumor cells JNJ-78278343 is being developed for the treatment of metastatic castration-resistant prostate cancer mCRPC KLK2 expression is highly restricted in normal tissues and highly enriched in prostate adenocarcinoma and its expression is mostly maintained throughout disease progression making KLK2 an attractive target for therapy This study will be conducted in 2 phases a Screening Phase up to 30 days a Treatment Phase start of study drug administration with an end of treatment EOT visit up to 30 plus 14 days after last dose of study drug or prior to the start of a new anticancer therapy whichever comes first The total duration of the study is up to 1 year and 10 months Safety assessment will include adverse events AEs including dose-limiting toxicity DLT serious adverse events SAEs physical examination vital signs electrocardiogram clinical safety laboratory assessments Eastern Cooperative Oncology Group ECOG performance status and neurologic examination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-005970-83 | EUDRACT_NUMBER | None | None |
| 78278343PCR1001 | OTHER | None | None |
| 2023-506585-31-00 | REGISTRY | EUCT number | None |