Phase 1/2 Study of UI-102 in Selected Advanced Cancers
Sponsor: United Immunity, co., Ltd.
ClinicalTrials ID:NCT07605962
This open-label, multi-center Phase 1/2 study evaluates UI-102's safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in advanced solid tumors. Eligible participants are adults with ECOG 0-1, confirmed advanced cancer, and measurable disease. UI-102 is administered in specified doses, with a focus on optimizing dosing in Phase 2. Participants must use effective birth control.
Patient Parameters
| Parameter | Options |
|---|
Program 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.
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
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| NEXT Oncology | 75039 | Dallas | Texas |
| NEXT Oncology | 77054 | Houston | Texas |
| NEXT Oncology | 78229 | San Antonio | Texas |
Get This Program In Your Inbox
You can sign up and apply your patients for this program.