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
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