NCT05958199

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

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

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 131 (estimated)
• Sponsor: NextPoint Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Metastatic Malignant Neoplasm

Interventions

Type	Name	Description
DRUG	NPX267	NPX267 will be administered by intravenous infusion every three weeks until documented disease progression or participant withdrawal

Timeline

• Start date: 2023-07-21
• Primary completion: 2025-09-20
• Completion: 2025-09-20
• First posted: 2023-07-24
• Last updated: 2025-06-27

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study