UI-102 in advanced cancers (phase 1/2) first-in-human

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, multi-center phase 1/2 trial evaluating UI-102, a TLR7/8 agonist delivered in a Cholesteryl Pullulan Nanoparticle, in patients with advanced solid tumors. The study will assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity, with the phase 2 portion focusing on efficacy and dose optimization. Eligible participants have measurable disease, adequate tumor tissue, prior therapy, and good performance status, and must meet contraception and other criteria. The trial will be conducted at select sites in Texas under a non-randomized design. No collaborators are listed beyond the sponsor, United Immunity, Co., Ltd.

Why it matters

Who can join: the full rules

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

Where it's running

• NEXT Oncology
  Dallas, Texas, United States Recruiting
• NEXT Oncology
  Houston, Texas, United States Recruiting
• NEXT Oncology
  San Antonio, Texas, United States Recruiting

Study contacts

• Study coordinator: K Hashimoto, MD
• Email: clinical-contact@unitedimmunity.co.jp
• Phone: +81 (0)3-6265-1670

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.