A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid
Specific proteins found in tumors help the tumors spread and grow. People with solid tumors often have a protein called TROP2 in their tumor. ASP2998 is being developed to attach to TROP2 and then attack the tumor cells in people with solid tumors. ASP2998 will either be given by itself, or given together with one or m
| Condition(s) | Locally Advanced or Metastatic Malignant Solid Tumors |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | Specific proteins found in tumors help the tumors spread and grow. People with solid tumors often have a protein called TROP2 in their tumor. ASP2998 is being developed to attach to TROP2 and then attack the tumor cells in people with solid tumors. ASP2998 will either be given by itself, or given together with one or more of standard cancer treatments pembrolizumab, carboplatin, and enfortumab vedotin. This is an early development study to collect information about ASP2998 in people with solid tumors. In this study ASP2998 will be given to humans for the first time. Early development studies are mostly about safety, but also to find the most suitable dose. Other aims are to check if ASP2998 shows signs of reducing tumor growth, to learn how the body processes ASP2998, and to check if there |
| Who can participate | Inclusion Criteria: * For the ASP2998 monotherapy dose escalation (excluding urothelial and non-small cell lung cancer (NSCLC) tumor-specific backfill participants), the following criteria apply: * Participant has a confirmed diagnosis of locally advanced unresectable or metastatic solid tumors. * Participant has progressed on, is ineligible for, or has refused all available standard therapies (no limit to the number of prior treatment regimens). * Prior exposure to TROP2, stimulator of interferon genes (STING) agonist or topoisomerase I (TopI) directed therapy is allowed. * Participant must have one of the following malignancies: Urothelial carcinoma, NSCLC (nonsquamous cell histology), Gastric/ gastroesophageal junction (GEJ) cancer, Breast cancer (human epidermal growth factor receptor |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Astellas Pharma Global Development, Inc. |
| Locations | Hackensack, New Jersey, United States; New Hyde Park, New York, United States; Nashville, Tennessee, United States; Fairfax, Virginia, United States; Kashiwa-shi, Chiba, Japan; Chuo-ku, Tokyo, Japan (+1 more sites) |
| Start date | 2026-02-05 |
| NCT ID | NCT07287995 |
| Official listing | https://clinicaltrials.gov/study/NCT07287995 |