Phase 1/2 Study of UI-102 in Selected Advanced Cancers

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Cancer

In brief

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.

Key facts

Study ID

NCT07605962

Run by

United Immunity, co., Ltd.

People needed

140

Starts

2026-05-20

Expected to finish

2031-03-31

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• NEXT Oncology — Dallas, Texas, United States (enrolling)
• NEXT Oncology — Houston, Texas, United States (enrolling)
• NEXT Oncology — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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