NCT07605962

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_1

Timeline
58mo left

Started May 2026

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Mar 2031

First Submitted

Initial submission to the registry

May 18, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

May 20, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2031

Last Updated

June 3, 2026

Status Verified

June 1, 2026

Enrollment Period

3.9 years

First QC Date

May 18, 2026

Last Update Submit

June 1, 2026

Conditions

Advanced Cancer

Keywords

metastatic solid tumorsadvanced solid tumors

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

UI-102 Monotherapy, IV infusion

EXPERIMENTAL

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

UI-102 Combination Therapy, IV infusion

EXPERIMENTAL

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

Interventions

UI-102DRUG

Specified dose on specified days

UI-102 Combination Therapy, IV infusionUI-102 Monotherapy, IV infusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1,
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

NEXT Oncology

Dallas, Texas, 75039, United States

RECRUITING

NEXT Oncology

Houston, Texas, 77054, United States

RECRUITING

NEXT Oncology

San Antonio, Texas, 78229, United States

RECRUITING

Central Study Contacts

K Hashimoto, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Open Label Multi Center Non Randomized Study
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Initial dose escalation cohort followed by expansion and phase II study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2026

First Posted

May 26, 2026

Study Start

May 20, 2026

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

March 31, 2031

Last Updated

June 3, 2026

Record last verified: 2026-06

Locations

US(3)