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

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

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

Conditions2

Interventions1

Locations3 sites

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