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
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.
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
Arms & interventions
- DrugUI-102
Specified dose on specified days
Outcome measures
Primary
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
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
Study locations (3)
NEXT Oncology
Dallas, Texas, 75039
NEXT Oncology
Houston, Texas, 77054
NEXT Oncology
San Antonio, Texas, 78229