Phase 1/2 Study of UI-102 in Selected Advanced Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: UI-102.
- Who it may be relevant to
- Registry conditions: Advanced Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
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
Interventions
- Drug UI-102
Specified dose on specified days
Primary outcome measures
- 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]
Secondary outcome measures (7)
- Dose Escalation: Best Overall Response (BOR) as Determined by RECIST v1.1 with Monotherapy and in Combination [Time frame: Up to 48 months]
- Dose Escalation: Duration of Response (DOR) as Determined by RECIST v1.1 with I Monotherapy and in Combination [Time frame: Up to 48 months]
- Dose Escalation: Progression-free survival (PFS) as Determined by RECIST v1.1 with Monotherapy and in Combination [Time frame: Up to 48 months]
- Expansion: Duration of Response (DOR) as Determined by RECIST v1.1 with Monotherapy and combination [Time frame: Up to 48 months]
- Expansion: Progression-free survival (PFS) as Determined by RECIST v1.1 with Monotherapy and combination [Time frame: Up to 48 months]
- Plasma Concentration of UI-102 [Time frame: Up to 48 months]
- Incidence of anti-UI-102 Antibody Formation [Time frame: Up to 48 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- NEXT Oncology — Dallas
- NEXT Oncology — Houston
- NEXT Oncology — San Antonio
Identifiers
NCT: NCT07605962 · UI-102-CT01