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

Part of paid clinical trials in Dallas, Texas.

Sponsor
United Immunity, co., Ltd.
Study ID
NCT07605962
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • UI-102 — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
May 20, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2030
Completion
Mar 31, 2031

Study Design

Enrollment
140 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Dose Escalation: Percentage of participants with ≥1 dose-limiting toxicity (DLT) [ Time Frame: Up to 24 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
NEXT OncologyDallasTexas75039
Clinical Trial Navigator
[email protected]
972-893-8800
NEXT OncologyHoustonTexas77054
Clinical Trial Navigator
[email protected]
832-384-7912
NEXT OncologySan AntonioTexas78229
Clinical Trial Navigator
[email protected]
210-580-9521

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