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Brief Title: A Study of NPX887 for Participants With Solid Tumors Known to Express HHLA2/B7-H7
Official Title: A Phase 1a/1b Dose Escalation and Dose Expansion Study of NPX887 in Participants With Solid Tumor Malignancies Known to Express HHLA-2/B7-H7
Study ID: NCT06240728
Brief Summary: NPX887 is a human, antagonistic immunoglobulin G1 (IgG1) monoclonal antibody targeting HHLA2 (B7-H7) 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 in participants whose cancers are known to express HHLA2 (B7-H7).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? 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 (Dose Expansion). 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 activity in multiple disease-specific cohorts and compare the efficacy of the higher and lower doses chosen in Phase 1a. Throughout the study, 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Johns Hopkins University, Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center (BIDMC), Boston, Massachusetts, United States
MD Anderson Cancer Center, Houston, Texas, United States
Next Oncology, San Antonio, Texas, United States
NEXT Oncology-Fairfax, Fairfax, Virginia, United States