A Study of NPX887 for Participants With Solid Tumors Known to Express B7-H7/HHLA2
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 tu
| Condition(s) | Metastatic Malignant Neoplasm |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * Histologically or cytologically confirmed recurrent, metastatic solid tumor refractory to, or intolerant of, standard of care therapy in one of the following indications: * Phase 1a (Dose Escalation): Non-small cell lung carcinoma (NSCLC), small cell lung carcinoma (SCLC), renal cell carcinoma (RCC), colorectal carcinoma (CRC), gastric and gastro-esophageal carcinoma, esophageal adenocarcinoma, biliary tract cancers, ovarian carcinoma, and other solid tumor types known to express B7-H7/HHLA2. * Phase 1b including Part 1b (Dose Expansion) and Part 1c (Randomized Dose Comparison): participants who have clear cell RCC, EGFR mutant lung adenocarcinoma, or gastric/GEJ adenocarcinoma. * In Phase 1b, participants must have confirmed B7-H7/HHLA2 expression in their tumor dete |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | NextPoint Therapeutics, Inc. |
| Locations | Baltimore, Maryland, United States; Boston, Massachusetts, United States; The Bronx, New York, United States; Houston, Texas, United States; San Antonio, Texas, United States; Fairfax, Virginia, United States (+2 more sites) |
| Start date | 2024-01-22 |
| NCT ID | NCT06240728 |
| Official listing | https://clinicaltrials.gov/study/NCT06240728 |