Ignite Creation Date:
2024-07-17 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465069
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-13
Brief Title:
A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Phase 1a1b Study of LY4052031 an Antibody-Drug Conjugate Targeting Nectin-4 in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-09
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:
NEXUS-01
Brief Summary:
The purpose of this study is to find out whether the study drug LY4052031 is safe tolerable and effective in participants with advanced or metastatic solid tumors including urothelial cancer The study is conducted in two parts - phase Ia dose-escalation dose-optimization and phase Ib dose-expansion The study will last up to approximately 4 years
Detailed Description:
This is a Phase 1a1b multicenter open-label study in participants with advanced or metastatic solid tumor malignancies known to express Nectin 4 This study is comprised of two phases Dose Escalation and Dose Optimization 1a and Dose expansion 1b Phase 1a will assess the safety tolerability and pharmacokinetics of LY4052031 to determine the recommended phase 2 dose RP2Doptimal dose Phase 1b will evaluate efficacy and safety of LY4052031 at the RP2Doptimal dose in expansion cohorts based on tumor type andor treatment history
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| J5I-OX-JZYA | OTHER | None | None |
| 2024-512927-36-00 | CTIS | None | None |