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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Cancer
• Intervention / Treatment: Drug: UI-102

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

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: K Hashimoto, MD; Phone Number: +81 (0)3-6265-1670; Email: clinical-contact@unitedimmunity.co.jp

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75039
      • NEXT Oncology
      • Contact: Phone Number: 972-893-8800
    • Houston, Texas, United States, 77054
      • NEXT Oncology
      • Contact: Phone Number: 832-384-7900
    • San Antonio, Texas, United States, 78229
      • NEXT Oncology
      • Contact: Phone Number: 210-580-9500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; UI-102 monotherapy administered intravenously. This arm includes Phase I dose escalation, backfill cohorts, and cohort expansion in participants with selected locally advanced and/or metastatic solid tumors.	Drug: UI-102; Specified dose on specified days
Experimental: Arm B; UI-102 administered intravenously in combination with standard-of-care agents commonly used. This arm includes dose escalation, dose optimization, and cohort expansion.	Drug: UI-102; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose Escalation: Percentage of participants with ≥1 dose-limiting toxicity (DLT)	Up to 24 months
Dose Escalation: Percentage of participants with ≥1 adverse event (AE)	Up to 24 months
Dose Escalation: Percentage of participants with ≥1 serious adverse event (SAE)	Up to 24 months
Dose Escalation: Percentage of participants with significant changes in electrocardiogram (ECG) recordings	Up to 24 months
Dose Escalation: Percentage of participants with significant changes in vital signs	Up to 24 months
Dose Escalation: Percentage of participants with significant changes in laboratory results	Up to 24 months
Dose Escalation: Percentage of participants with a dose interruption, reduction, or discontinuation	Up to 24 months
Expansion: Best Overall Response (BOR) as Determined by RECIST v1.1	Up to 48 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Dose Escalation: Best Overall Response (BOR) as Determined by RECIST v1.1 with Monotherapy and in Combination	Up to 48 months
Dose Escalation: Duration of Response (DOR) as Determined by RECIST v1.1 with I Monotherapy and in Combination	Up to 48 months
Dose Escalation: Progression-free survival (PFS) as Determined by RECIST v1.1 with Monotherapy and in Combination	Up to 48 months
Expansion: Duration of Response (DOR) as Determined by RECIST v1.1 with Monotherapy and combination	Up to 48 months
Expansion: Progression-free survival (PFS) as Determined by RECIST v1.1 with Monotherapy and combination	Up to 48 months
Plasma Concentration of UI-102	Up to 48 months
Incidence of anti-UI-102 Antibody Formation	Up to 48 months

Collaborators and Investigators

• Sponsor: United Immunity, co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 25, 2026
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2031

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: advanced solid tumors; metastatic solid tumors
• Other Study ID Numbers: UI-102-CT01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No