Phase 1/2 Study of UI-102 in Selected Advanced Cancers

Conditions: Advanced Cancer

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE1, PHASE2

Enrollment: 140

Sponsor: United Immunity, co., Ltd.

Location: NEXT Oncology Dallas Texas

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.

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07605962). StuddyBuddy aggregates publicly available trial information.