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.

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

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

Open Label Multi Center Non Randomized Study