A Phase I/II Open-Label, Dose Escalation, Dose Optimization, and Cohort Expansion Trial to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of UI-102, a Novel Cholesteryl Pullulan (CHP) Nanoparticle-formulated TLR7/8 Agonist in Patients With Selected Locally Advanced and/or Metastatic Solid Tumors
United Immunity, co., Ltd.
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.
Description
This phase 1/2 , open-labelled, multi-center study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics, and preliminary clinical activities of UI-102 in patients with advanced solid tumors. Phase 2 part is designed to assess the efficacy and safety as well as to optimize the dosing amount of UI-102
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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, * Ong…
Interventions
- DrugUI-102
Specified dose on specified days
Locations (3)
- NEXT OncologyDallas, Texas
- NEXT OncologyHouston, Texas
- NEXT OncologySan Antonio, Texas