Phase 1/2 Study of UI-102 in Selected Advanced Cancers
This phase 1/2 first-in-human study is designed to assess the safety and efficacy of UI-102, a TLR7/8 agonist encapsulated in a Cholesteryl Pullulan Nanoparticle.
| Condition(s) | Advanced Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | This phase 1/2 first-in-human study is designed to assess the safety and efficacy of UI-102, a TLR7/8 agonist encapsulated in a Cholesteryl Pullulan Nanoparticle. |
| Who can participate | Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, * 18 Years and Older (adult, older adult), * Histologically confirmed advanced cancer, * Archived or fresh tumor tissue sample that must be confirmed as adequate, * Evaluable/Measurable disease per RECIST 1.1, * Previously received applicable standard treatments, * Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control Exclusion Criteria: * central nervous system metastasis, * Ongoing or uncontrolled ascites or pleural effusion, * Significant ongoing toxicity from prior anticancer treatment, * Out-of-range laboratory values, * Clinically significant lung, heart, or autoimmune dis |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | United Immunity, co., Ltd. |
| Locations | Dallas, Texas, United States; Houston, Texas, United States; San Antonio, Texas, United States |
| Start date | 2026-05-20 |
| NCT ID | NCT07605962 |
| Official listing | https://clinicaltrials.gov/study/NCT07605962 |