Advanced Cancer
Conditions
Keywords
metastatic solid tumors, advanced solid tumors
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.
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
DRUGUI-102
Specified dose on specified days
Sponsors
United Immunity, co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label Multi Center Non Randomized Study
Intervention model description
Initial dose escalation cohort followed by expansion and phase II study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Plasma Concentration of UI-102 | Up to 48 months |
| Incidence of anti-UI-102 Antibody Formation | Up to 48 months |
Countries
United States
Contacts
CONTACTK Hashimoto, MD
Outcome results
None listed