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
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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