Clinical trial · Interventional
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
NCT07605962CI-TRIAL-00113473recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| UI-102 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- UI-102 Monotherapy, IV infusion
- description
- 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.
- interventionNames
- Drug: UI-102
- type
- EXPERIMENTAL
- label
- UI-102 Combination Therapy, IV infusion
- description
- UI-102 administered intravenously in combination with standard-of-care agents commonly used. This arm includes dose escalation, dose optimization, and cohort expansion.
- interventionNames
- Drug: UI-102
Primary outcomes (8)
- measure
- Dose Escalation: Percentage of participants with ≥1 dose-limiting toxicity (DLT)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.