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NCT07605962PHASE1, PHASE2Recruiting

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

United Immunity, co., Ltd.

Start Date

5/20/2026

Completion Date

3/31/2031

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.

Detailed 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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

UI-102

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Conditions

Advanced Cancer

Locations

NEXT Oncology

Dallas, Texas 75039

United States

NEXT Oncology

Houston, Texas 77054

United States

NEXT Oncology

San Antonio, Texas 78229

United States