Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05958199
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2023-06-23
Brief Title:
A Study of NPX267 for Subjects With Solid Tumors Known to Express HHLA2B7-H7
Sponsor:
NextPoint Therapeutics Inc
Organization:
NextPoint Therapeutics Inc
Study Overview
Official Title:
A Phase 1a1b Dose-EscalationDose-Expansion Study of NPX267 in Subjects With Solid Tumors Known to Express HHLA2B7-H7
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
NPX267 is an antibody drug targeting the inhibitory receptor for B7-H7 HHLA2 which may control evasion of the immune response in tumors The goal of this clinical trial is to learn whether NPX267 is safe and tolerable in patients whose cancers are known to express HHLA2 including epidermal growth factor receptor EGFR mutant non-small cell lung cancer The main questions it aims to answer are
what is an appropriate dose to be given to patients
are the side effects of treatment manageable
Participants will be evaluated for participation in the study Patients who are treated will receive an intravenous infusion of NPX267 every three weeks if their disease has not progressed Patients will be closely monitored by the treating physician
what is an appropriate dose to be given to patients
are the side effects of treatment manageable
Participants will be evaluated for participation in the study Patients who are treated will receive an intravenous infusion of NPX267 every three weeks if their disease has not progressed Patients will be closely monitored by the treating physician
Detailed Description:
This trial is divided into two parts The first part dose escalation will test different doses of drug to find a dose for part two In the second part dose expansion more patients will be tested to see if the drug has an effect on patients tumors
Throughout the study data will be collected to characterize the clinical activity of the drug Samples of blood will be taken to help in an understanding of how the drug behaves in the body by assessing the amount of drug in the blood over time pharmacokinetics and changes in blood components pharmacodynamics and safety Tumor imaging by computed tomography CT or magnetic resonance imaging MRI will be done about every nine weeks to assess NPX267 impact on tumor growth
Throughout the study data will be collected to characterize the clinical activity of the drug Samples of blood will be taken to help in an understanding of how the drug behaves in the body by assessing the amount of drug in the blood over time pharmacokinetics and changes in blood components pharmacodynamics and safety Tumor imaging by computed tomography CT or magnetic resonance imaging MRI will be done about every nine weeks to assess NPX267 impact on tumor growth
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