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

ClinicalTrials.gov ID

NCT07605962

Lead Sponsor

United Immunity, co., Ltd.INDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 1Phase 2

Enrollment

140Estimated

Last Update Posted

Jun 3, 2026Actual

Start Date

May 20, 2026Actual

Primary Completion Date

Mar 31, 2030Estimated

Completion Date

Mar 31, 2031Estimated

Official Title

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

Brief 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

• Advanced Cancer

• UI-102

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Non-Randomized

Interventional Model

Sequential Assignment

Masking

None (Open Label)

Lead Sponsor

United Immunity, co., Ltd.INDUSTRY

emorales@nextoncology.com832-384-7912

jgeorg@nextoncology.com210-580-9521

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