Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376253
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-02
Brief Title:
A Phase I Study of 177LuLu-EVS459 in Patients With Ovarian and Lung Cancers
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase I Open-label Multi-center Study to Evaluate the Safety Tolerability Dosimetry and Preliminary Activity of 177LuLu-EVS459 in Patients With Ovarian and Lung Cancers
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:
None
Brief Summary:
The purpose of this study is to evaluate the safety tolerability dosimetry and preliminary efficacy of 177LuLu-EVS459 and the safety and imaging properties of 68GaGa-EVS459 in patients aged 18 years with advanced high-grade serous ovarian cancer OC or locally advanced unresectable or metastatic non-squamous non-small cell lung carcinoma non-sq NSCLC
Detailed Description:
The study will be done in two parts The first part is called escalation and the second part is called expansion In both parts of the study patients will initially be imaged with a 68GaGa EVS459 positron emission tomography PETcomputed tomography CT or PETmagnetic resonance imaging MRI scan In the escalation part different doses of 177LuLu-EVS459 will then be tested to identify recommended doses RDs for further evaluation The expansion part of the study will examine the safety and preliminary efficacy of 177LuLu-EVS459 at the RDs determined during the escalation part The end of study will occur when at least 80 of the patients in the expansion part have completed the follow-up for disease progression or discontinued from the study for any reason and all patients have completed treatment and the 36-month long-term follow-up period
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 |
|---|---|---|---|
| 2023-507674-41-00 | OTHER | CTIS | None |