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Phase 1/2 Study of UI-102 for Advanced Cancers

This is a Phase 1/2 study testing a new treatment called UI-102 for people with advanced cancer. UI-102 is a drug delivered using a special nanoparticle (a tiny particle). The study aims to find out how safe UI-102 is, what side effects it might cause, and if it shows any promise in treating cancer. To join, you must be 18 or older, have a confirmed advanced cancer, and your cancer must be measurable. The study is currently unclear on its recruitment status, but plans to enroll about 140 participants. Success in the first part of the study will be measured by how many participants experience dose-limiting toxicities (serious side effects), any adverse events (side effects), or serious adverse events over up to 24 months.

Study design
This is a Phase 1/2, open-label (meaning both you and the study team know what treatment you are receiving), multi-center study. It plans to enroll about 140 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07605962

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
United Immunity, co., Ltd.
~140 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:UI-102

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Escalation: Percentage of participants with ≥1 dose-limiting toxicity (DLT)
Measured over Up to 24 months
+7 more outcomes measured

Conditions

Advanced Cancer

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Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • NEXT Oncology

    Dallas, Texasstudy coordinator listed

    Recruiting

  • NEXT Oncology

    Houston, Texasstudy coordinator listed

    Recruiting

  • NEXT Oncology

    San Antonio, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

K Hashimoto, MD
[email protected]
+81 (0)3-6265-1670
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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) recordingsUp to 24 months
  • Dose Escalation: Percentage of participants with significant changes in vital signsUp to 24 months
  • Dose Escalation: Percentage of participants with significant changes in laboratory resultsUp to 24 months
  • Dose Escalation: Percentage of participants with a dose interruption, reduction, or discontinuationUp to 24 months
  • Expansion: Best Overall Response (BOR) as Determined by RECIST v1.1Up to 48 months