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

United Immunity, co., Ltd.

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Cancer

Treatments: Drug: UI-102

Study type: Interventional

Funder types: Industry

Identifiers

NCT07605962

UI-102-CT01

Details and patient eligibility

About

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.

Full 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

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

UI-102 Monotherapy, IV infusion

Experimental group

Description:

UI-102 monotherapy administered intravenously. This arm includes Phase I dose escalation, backfill cohorts, and cohort expansion in participants with selected locally advanced and/or metastatic solid tumors.

Treatment:

Drug: UI-102

UI-102 Combination Therapy, IV infusion

Experimental group

Description:

UI-102 administered intravenously in combination with standard-of-care agents commonly used. This arm includes dose escalation, dose optimization, and cohort expansion.

Treatment:

Drug: UI-102