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A Study of NPX267 for Subjects With Solid Tumors Known to Express HHLA2/B7-H7

Metastatic Malignant Neoplasm Clinical Trial

Official title:
A Phase 1a/1b, Dose-Escalation/Dose-Expansion Study of NPX267 in Subjects With Solid Tumors Known to Express HHLA2/B7-H7

Clinical Trial 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.

Clinical Trial 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 patient's 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05958199
Study type Interventional
Source NextPoint Therapeutics, Inc.
Contact Leena Gandhi, MD, PhD
Phone 857 209-0486
Email NPX267-001@nextpointtx.com
Status Recruiting
Phase Phase 1
Start date July 21, 2023
Completion date January 2026
View Details
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