Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-25 @ 4:02 PM
Study NCT ID:
NCT05888857
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-13
First Post:
2023-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MEDI5752 in Patients With Mature Tertiary Lymphoid Structures Solid Tumors.
Sponsor:
Institut Bergonié
Organization:
Study Overview
Official Title:
A Multicentric Phase II Trial Evaluating MEDI5752 in Patients With Mature Tertiary Lymphoid Structures Solid Tumors.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
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:
TAYLOR
Brief Summary:
Multicentric, prospective, multi-indication, single-treatment arm, open-label phase II trial assessing the efficacy of MEDI5752
Detailed Description:
Multicentric, prospective, multi-indication, single-treatment arm, open-label phase II trial assessing the efficacy of MEDI5752.
Patients with mature tertiary lymphoid structures advanced solid tumors will be included in two independent cohorts:
* Cohort A: patients with TLS+ IO-naïve solid tumor (miscellaneous)
* Cohort B: patients with TLS+ PD1/PDL1-experienced solid tumor (miscellaneous) Each cohort will rely on a two-stage three-outcome design as described in Sargent et al.
Patients with mature tertiary lymphoid structures advanced solid tumors will be included in two independent cohorts:
* Cohort A: patients with TLS+ IO-naïve solid tumor (miscellaneous)
* Cohort B: patients with TLS+ PD1/PDL1-experienced solid tumor (miscellaneous) Each cohort will rely on a two-stage three-outcome design as described in Sargent et al.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2023-503451-94 | OTHER | EU-CTR | View |