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Phase 1/2 Study of UI-102 in Selected Advanced Cancers
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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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 disease, * Ongoing requirement for immunosuppressive treatment, * Significant secondary malignancy, * Hypersensitivity to study drug or excipients, * Pregnant or lactating, * Ongoing active infection
About the study
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.
What is being tested
- UI-102 (drug)
Sponsor: United Immunity, co., Ltd. · Participants: 140 · Started: May 20, 2026
Contact the study team
- K Hashimoto, MD · Phone: +81 (0)3-6265-1670
Official record on ClinicalTrials.gov — NCT07605962
Locations in the U.S.
| Texas | NEXT Oncology, Dallas NEXT Oncology, Houston NEXT Oncology, San Antonio |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.