Advanced CancerPhase 1/2NCT07605962
Phase 1/2 Study of UI-102 in Selected Advanced Cancers
A Phase 1/2 study testing UI-102 in people with Advanced Cancer, run by United Immunity, co., Ltd. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- UI-102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 May 2026to 31 Mar 2031
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 10Show fewer
- Significant secondary malignancy,
- Hypersensitivity to study drug or excipients,
- Pregnant or lactating,
- Ongoing active infection
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
NEXT Oncology
Dallas, Texas, 75039
Clinical Trial Navigator, 972-893-8800, fakinwale@nextoncology.com
- Recruiting
NEXT Oncology
Houston, Texas, 77054
Clinical Trial Navigator, 832-384-7912, emorales@nextoncology.com
- Recruiting
NEXT Oncology
San Antonio, Texas, 78229
Clinical Trial Navigator, 210-580-9521, jgeorg@nextoncology.com
About this study
Official title: A Phase I/II Open-Label, Dose Escalation, Dose Optimization, and Cohort Expansion Trial to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of UI-102, a Novel Cholesteryl Pullulan (CHP) Nanoparticle-formulated TLR7/8 Agonist in Patients With Selected Locally Advanced and/or Metastatic Solid Tumors
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.
Read the detailed 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
- Conditions
- Advanced Cancer
- Being tested
- UI-102
- Keywords
- metastatic solid tumors, advanced solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UI-102Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| UI-102 Monotherapy, IV infusion | Experimental | 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. Receives: Drug: UI-102 |
| UI-102 Combination Therapy, IV infusion | Experimental | UI-102 administered intravenously in combination with standard-of-care agents commonly used. This arm includes dose escalation, dose optimization, and cohort expansion. Receives: Drug: UI-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation: Percentage of participants with ≥1 dose-limiting toxicity (DLT)
Measured: Up to 24 months
Dose Escalation: Percentage of participants with ≥1 adverse event (AE)
Measured: Up to 24 months
Dose Escalation: Percentage of participants with ≥1 serious adverse event (SAE)
Measured: Up to 24 months
Dose Escalation: Percentage of participants with significant changes in electrocardiogram (ECG) recordings
Measured: Up to 24 months
Dose Escalation: Percentage of participants with significant changes in vital signs
Measured: Up to 24 months
Dose Escalation: Percentage of participants with significant changes in laboratory results
Measured: Up to 24 months
Dose Escalation: Percentage of participants with a dose interruption, reduction, or discontinuation
Measured: Up to 24 months
Expansion: Best Overall Response (BOR) as Determined by RECIST v1.1
Measured: Up to 48 months
Secondary outcomes (7)
Dose Escalation: Best Overall Response (BOR) as Determined by RECIST v1.1 with Monotherapy and in Combination
Measured: Up to 48 months
Dose Escalation: Duration of Response (DOR) as Determined by RECIST v1.1 with I Monotherapy and in Combination
Measured: Up to 48 months
Dose Escalation: Progression-free survival (PFS) as Determined by RECIST v1.1 with Monotherapy and in Combination
Measured: Up to 48 months
Expansion: Duration of Response (DOR) as Determined by RECIST v1.1 with Monotherapy and combination
Measured: Up to 48 months
Expansion: Progression-free survival (PFS) as Determined by RECIST v1.1 with Monotherapy and combination
Measured: Up to 48 months
Plasma Concentration of UI-102
Measured: Up to 48 months
Incidence of anti-UI-102 Antibody Formation
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start20 May 2026
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Initial dose escalation cohort followed by expansion and phase II study
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United Immunity, co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605962
- Sponsor's protocol ID
- UI-102-CT01
- Status last verified
- Jun 2026
- First submitted
- 18 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Open-Label, Dose Escalation, Dose Optimization, and Cohort Expansion Trial to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of UI-102, a Novel Cholesteryl Pullulan (CHP) Nanoparticle-formulated TLR7/8 Agonist in Patients With Selected Locally Advanced and/or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07605962
- Acronym / sponsor ID
- UI-102-CT01
- Conditions
- Advanced Cancer
- Keywords
- metastatic solid tumors, advanced solid tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- United Immunity, co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 May 2026 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Initial dose escalation cohort followed by expansion and phase II study
| Arm | Type | Receives |
|---|---|---|
| UI-102 Monotherapy, IV infusion | Experimental | Drug: UI-102UI-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. |
| UI-102 Combination Therapy, IV infusion | Experimental | Drug: UI-102UI-102 administered intravenously in combination with standard-of-care agents commonly used. This arm includes dose escalation, dose optimization, and cohort expansion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UI-102Specified dose on specified days | Drug | UI-102 Combination Therapy, IV infusion, UI-102 Monotherapy, IV infusion |
Primary outcome
Dose Escalation: Percentage of participants with ≥1 dose-limiting toxicity (DLT)
Time frame: Up to 24 months
Dose Escalation: Percentage of participants with ≥1 adverse event (AE)
Time frame: Up to 24 months
Dose Escalation: Percentage of participants with ≥1 serious adverse event (SAE)
Time frame: Up to 24 months
Dose Escalation: Percentage of participants with significant changes in electrocardiogram (ECG) recordings
Time frame: Up to 24 months
Dose Escalation: Percentage of participants with significant changes in vital signs
Time frame: Up to 24 months
Dose Escalation: Percentage of participants with significant changes in laboratory results
Time frame: Up to 24 months
Dose Escalation: Percentage of participants with a dose interruption, reduction, or discontinuation
Time frame: Up to 24 months
Expansion: Best Overall Response (BOR) as Determined by RECIST v1.1
Time frame: Up to 48 months
7 secondary outcomes
Dose Escalation: Best Overall Response (BOR) as Determined by RECIST v1.1 with Monotherapy and in Combination
Time frame: Up to 48 months
Dose Escalation: Duration of Response (DOR) as Determined by RECIST v1.1 with I Monotherapy and in Combination
Time frame: Up to 48 months
Dose Escalation: Progression-free survival (PFS) as Determined by RECIST v1.1 with Monotherapy and in Combination
Time frame: Up to 48 months
Expansion: Duration of Response (DOR) as Determined by RECIST v1.1 with Monotherapy and combination
Time frame: Up to 48 months
Expansion: Progression-free survival (PFS) as Determined by RECIST v1.1 with Monotherapy and combination
Time frame: Up to 48 months
Plasma Concentration of UI-102
Time frame: Up to 48 months
Incidence of anti-UI-102 Antibody Formation
Time frame: Up to 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing UI-102 in people with Advanced Cancer, run by United Immunity, co., Ltd. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact K Hashimoto, MD (+81 (0)3-6265-1670, clinical-contact@unitedimmunity.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation: Percentage of participants with ≥1 dose-limiting toxicity (DLT) (time frame: Up to 24 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.