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
United Immunity, co., Ltd.
140 participants
May 20, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1,
- 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 Criteria10
- 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
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Interventions
Specified dose on specified days
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07605962