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.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Specified dose on specified days
NEXT Oncology
Dallas, Texas, United States
RECRUITINGNEXT Oncology
Houston, Texas, United States
RECRUITINGNEXT Oncology
San Antonio, Texas, United States
RECRUITINGDose 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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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