A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors
This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants with Advanced Solid Tumors
| Condition(s) | Advanced Solid Tumors |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants with Advanced Solid Tumors |
| Who can participate | Inclusion Criteria: 1. Written informed consent is obtained prior to any procedures that are not considered standard of care 2. ≥18 years of age. 3. In Part 1: 1. Participants with histologically or cytologically confirmed advanced solid tumors, who have failed or are ineligible for standard of care therapies. 2. Have progressed on at least one prior systematic anti-tumor regimen, and presence of at least one evaluable lesion according to RECIST Version 1.1. Measurable lesions are required in the backfill period. 3. In the backfill period, eligible tumor types are limited to high-grade serous ovarian cancer, high-grade endometrioid ovarian cancer, USC, clear cell RCC, papillary RCC and adenocarcinoma of NSCLC without actionable mutation of epidermal growth factor receptor (EGFR). For parti |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | NextCure, Inc. |
| Locations | Orlando, Florida, United States; Atlanta, Georgia, United States; New Orleans, Louisiana, United States; Boston, Massachusetts, United States; Hackensack, New Jersey, United States; Buffalo, New York, United States (+11 more sites) |
| Start date | 2025-02-26 |
| NCT ID | NCT06792552 |
| Official listing | https://clinicaltrials.gov/study/NCT06792552 |