Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06240728
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-01-26
Brief Title:
A Study of NPX887 for Participants With Solid Tumors Known to Express B7-H7HHLA2
Sponsor:
NextPoint Therapeutics Inc
Organization:
NextPoint Therapeutics Inc
Study Overview
Official Title:
A Phase 1a1b Dose Escalation and Dose Expansion Study of NPX887 in Participants With Solid Tumor Malignancies Known to Express B7-H7HHLA2
Status:
RECRUITING
Status Verified Date:
2024-10
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:
NPX887 is a human antagonistic immunoglobulin G1 IgG1 monoclonal antibody targeting B7-H7 HHLA2 that may potentiate an anti-tumor immune response The goal of this first-in-human study is to learn whether NPX887 is safe and tolerable and shows a preliminary efficacy in participants with B7-H7 HHLA2 expressing tumors at selected doses The main questions it aims to answer are
what is an appropriate dose to be given to participants
are the side effects of treatment manageable
what is the preliminary anti-tumor activities
Participants who are treated will receive an intravenous IV infusion of NPX887 if their disease has not progressed and be closely monitored by the treating physicians
what is an appropriate dose to be given to participants
are the side effects of treatment manageable
what is the preliminary anti-tumor activities
Participants who are treated will receive an intravenous IV infusion of NPX887 if their disease has not progressed and be closely monitored by the treating physicians
Detailed Description:
This study is comprised of Phase 1a Dose Escalation and Phase 1b including Part 1b Dose Expansion and Part 1c Randomized Dose Comparison Phase 1a will test different doses of NPX887 to determine the optimal doses to continue with in Phase 1b In the Phase 1b more participants will be tested to evaluate preliminary activities in multiple disease-specific cohorts and compare the efficacy of the higher and lower doses chosen in Phase 1a
Throughout the study safety and preliminary efficacy data will be collected to characterize the clinical activity of NPX887 Samples of blood will be taken to help in an understanding of how NPX887 behaves in the body by assessing the amount of drug in the blood over time and changes in blood components Tumor tissue samples will be collected at screening and on-treatment stages for biomarker analysis and pharmacodynamics PD evaluation
Throughout the study safety and preliminary efficacy data will be collected to characterize the clinical activity of NPX887 Samples of blood will be taken to help in an understanding of how NPX887 behaves in the body by assessing the amount of drug in the blood over time and changes in blood components Tumor tissue samples will be collected at screening and on-treatment stages for biomarker analysis and pharmacodynamics PD evaluation
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