140 Participants NeededMy employer runs this trial

UI-102 for Cancer

Recruiting at 2 trial locations
KH
Overseen ByK Hashimoto, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: United Immunity, co., Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cancer treatment called UI-102. Researchers aim to determine if UI-102 is safe and effective for individuals with advanced cancer that has spread or cannot be surgically removed. The study consists of two parts: one administering UI-102 alone and another combining it with standard cancer treatments. Suitable participants have advanced cancer that hasn't responded to conventional treatments. As a Phase 1 and Phase 2 trial, this research focuses on understanding how UI-102 works in people and measuring its effectiveness in an initial group, offering participants the opportunity to be among the first to benefit from this innovative treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive treatment, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that UI-102, a new cancer treatment, is undergoing tests to determine its safety and effectiveness in people. Early studies suggest it might offer a safer option for treating "cold tumors," which do not respond well to the body's immune system.

Researchers are testing UI-102 both alone and in combination with other common cancer treatments. So far, the safety results align with expectations based on similar treatments. While risks always exist, no unexpected severe side effects have appeared in the studies so far.

Since this marks the first time UI-102 is tested in humans, not all possible side effects may be known yet. However, early trials indicate that people generally tolerate the treatment well. This ongoing research aims to better understand UI-102's safety and address any remaining questions.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about UI-102 for cancer treatment because it offers a novel approach compared to traditional chemotherapy and immunotherapy options. Unlike these existing treatments, UI-102 is an experimental drug that can be administered both as a monotherapy and in combination with other standard-of-care agents, potentially enhancing its effectiveness. A key feature of UI-102 is its innovative delivery via intravenous infusion, which is designed to maximize the drug's efficacy in targeting locally advanced and metastatic solid tumors. This dual approach allows for dose escalation and optimization, aiming to improve outcomes while potentially reducing side effects.

What evidence suggests that this trial's treatments could be effective for cancer?

Studies have shown that UI-102, a new cancer treatment, has promising effects. In this trial, participants may receive UI-102 as a monotherapy, which has demonstrated strong anti-cancer activity across various cancer types. Some studies found that more than half of the patients did not experience cancer progression for at least six months. Alternatively, participants may receive UI-102 combined with other standard treatments, which has yielded even better results, with up to 70% of patients responding positively. This suggests that UI-102 could help slow tumor growth and improve treatment outcomes for patients with advanced solid tumors.13678

Are You a Good Fit for This Trial?

This trial is for adults with certain advanced cancers who have already tried standard treatments or have no other good treatment options. Participants need to be in generally stable health and able to care for themselves.

Inclusion Criteria

I use effective birth control if I am sexually active and able to have children.
I am 18 years old or older.
I have a tumor tissue sample that is suitable for testing.
See 4 more

Exclusion Criteria

Pregnant or lactating
Out-of-range laboratory values
I currently have an active infection.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Phase I dose escalation to determine the safety and tolerability of UI-102

8-12 weeks

Dose Optimization

Phase II dose optimization to assess efficacy and optimize dosing of UI-102

12-16 weeks

Cohort Expansion

Cohort expansion to further evaluate the clinical activity of UI-102

16-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • UI-102

Trial Overview

The study is testing UI-102, a new drug designed to boost the immune system against cancer. It’s given as a nanoparticle formulation and this is the first time it’s being tested in humans, focusing on safety and early signs of effectiveness.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: UI-102 Monotherapy, IV infusionExperimental Treatment1 Intervention
Group II: UI-102 Combination Therapy, IV infusionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

United Immunity, co., Ltd.

Lead Sponsor

Citations

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

This arm includes Phase I dose escalation, backfill cohorts, and cohort expansion in participants with selected locally advanced and/or metastatic solid tumors.

News Details

“Importantly, with mPFS of 6.6 months, more than half of the patients in this trial had over 180 days of progression-free survival. These data ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31092375/

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