A Study of NPX887 for Participants With Solid Tumors Known to Express B7-H7/HHLA2
Start Date
1/22/2024
Completion Date
8/1/2027
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 dose(s). 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.
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 dose(s) 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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
NPX887
Conditions
Locations
Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21287
United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts 02215
United States
Albert Einstein Medical College Montefiore Medical Center
The Bronx, New York 10461
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Next Oncology
San Antonio, Texas 78229
United States
NEXT Oncology-Fairfax
Fairfax, Virginia 22031
United States
Severance Hospital, Yonsei University Health System
Seoul, 03722
South Korea
Samsung Medical Center
Seoul, 06351
South Korea