Recruiting
Phase 1
Phase 2

UI-102

Sponsor:

United Immunity, co., Ltd.

Code:

NCT07605962

Conditions

Advanced Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

UI-102

Study Details

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.

Conditions

Advanced Cancer

Study ID

NCT07605962

Start date

May 20, 2026

Status verified date

Jun, 2026

Completion date

Mar 31, 2031

Anticipated

Primary completion date

Mar 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

140 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: UI-102 Monotherapy, IV infusion

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.

experimental: UI-102 Combination Therapy, IV infusion

UI-102 administered intravenously in combination with standard-of-care agents commonly used. This arm includes dose escalation, dose optimization, and cohort expansion.

Interventions

UI-102

Specified dose on specified days

Primary outcome measure

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

Central Contacts and Locations

Central contacts

K Hashimoto, MD

+81 (0)3-6265-1670clinical-contact@unitedimmunity.co.jp

Locations

NEXT Oncology

Recruiting

Dallas, Texas, United States, 75039

Contacts

Clinical Trial Navigator

972-893-8800fakinwale@nextoncology.com

NEXT Oncology

Recruiting

Houston, Texas, United States, 77054

Contacts

Clinical Trial Navigator

832-384-7912emorales@nextoncology.com

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Clinical Trial Navigator

210-580-9521jgeorg@nextoncology.com

More Information

Sponsor

United Immunity, co., Ltd.

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Keywords

  • metastatic solid tumors
  • advanced solid tumors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by United Immunity, co., Ltd. on 2026-06-03.