Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562192
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
Phase I Study of 177LuLu-NNS309 in Patients With Pancreatic Lung Breast and Colorectal Cancers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase I Open-label Multi-center Study to Evaluate the Safety Tolerability Dosimetry and Preliminary Activity of 177LuLu-NNS309 in Patients With Pancreatic Lung Breast and Colorectal Cancers
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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-NNS309 and the safety and imaging properties of 68GaGa-NNS309 in patients aged 18 years with locally advanced or metastatic pancreatic ductal adenocarcinoma PDAC non-small cell lung cancer NSCLC HRHER2- ductal and lobular breast cancer BC triple negative breast cancer TNBC and colorectal cancer CRC
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-NNS309 positron emission tomography PET computed tomography CT or PETmagnetic resonance imaging MRI scan and will be evaluated for eligibility for 177LuLu-NNS309 treatment In the escalation part different doses of 177LuLu-NNS309 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-NNS309 at the RDs determined during the escalation part The end of study will occur when at least 80 of the patients per disease group 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?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None