30 Participants NeededMy employer runs this trial

SHY-ONC6 for Cancer

(Luca-1 Trial)

Recruiting at 3 trial locations
MM
CO
Overseen ByClinical Operations
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 treatment called SHY-ONC6 for individuals with advanced or metastatic solid tumors. The primary goals are to determine if SHY-ONC6 is safe, tolerable, and shows any signs of combating cancer. Participants must have specific types of cancer, such as breast, colon, or lung cancer, that have not responded to other treatments. Those with advanced cancer for whom standard therapies are ineffective or unsuitable might be suitable candidates for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that you cannot have concurrent anti-cancer treatment and must comply with prohibited medication restrictions. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that SHY-ONC6 is likely to be safe for humans?

Research has shown that SHY-ONC6 produced promising results in early studies. These studies found that the treatment effectively fought tumors and was generally well-tolerated in animals, meaning it worked well against tumors and caused few side effects. However, since SHY-ONC6 is being tested in humans for the first time, researchers are still assessing its safety for people. Phase 1 trials primarily focus on safety and aim to determine the appropriate dose that people can handle. While the animal studies are encouraging, human trials are necessary to confirm the safety of SHY-ONC6 for people.12345

Why do researchers think this study treatment might be promising?

SHY-ONC6 is unique because it is taken orally and offers a new way to target cancer cells through its novel mechanism. Unlike traditional options like chemotherapy, which often involve intravenous administration and can affect both healthy and cancerous cells, SHY-ONC6 is designed to work more selectively. Researchers are particularly excited about SHY-ONC6 because it uses a dose-escalation design to identify the most effective and safest dose, potentially leading to more personalized treatment options. This targeted approach could mean fewer side effects and improved outcomes for patients.

What evidence suggests that SHY-ONC6 might be an effective treatment for cancer?

Research has shown that SHY-ONC6, a new pill under study in this trial, produced promising results in early studies. It stopped tumors from growing and even caused them to shrink in various cancer models. The drug effectively targeted tumors and was well-tolerated in animal studies. SHY-ONC6 blocks the proteasome, a cellular component that breaks down proteins and aids cancer cell survival. These findings suggest that SHY-ONC6 could provide a new treatment option for advanced and difficult-to-treat cancers.12367

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors, such as breast, colon, lung, liver, stomach, prostate cancer and others. Participants must have tried standard treatments that no longer work or can't be tolerated.

Inclusion Criteria

Life expectancy >3 months
Negative serum pregnancy test and use of effective contraception through 90 days after last dose for women of childbearing potential
I am 18 years old or older.
See 8 more

Exclusion Criteria

I have not had a serious infection needing medication in the past 2 weeks.
I do not have active hepatitis B, hepatitis C, or uncontrolled HIV infection.
Any medical or psychiatric disorders affecting compliance and/or interpretation of study results
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Phase 1a)

Participants receive SHY-ONC6 with sequential dose levels evaluated under accelerated titration and BOIN dose-escalation design

21 days per cycle
Multiple visits per cycle

Dose Expansion (Phase 1b)

Participants evaluated in disease-specific expansion cohorts and receive SHY-ONC6 at the RP2D range identified in Phase 1a

21 days per cycle
Multiple visits per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days after last dose

What Are the Treatments Tested in This Trial?

Interventions

  • SHY-ONC6

Trial Overview

The study is testing SHY-ONC6, a new type of drug called a proteasome inhibitor. It aims to find the safest dose and see how well it works against various cancers. The trial has two parts: first finding the right dose, then expanding to more patients.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: SHY-ONC6Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

SHY Therapeutics

Lead Sponsor

Citations

1.

shytherapeutics.com

shytherapeutics.com/pipeline

SHY Therapeutics Pipeline | First-in-Class Programs

SHY-ONC6 shows robust oral efficacy, achieving well over 100% tumor growth inhibition (regression) in a range of human-derived tumor models. ...

SHY Therapeutics Doses First Patient in SHY-ONC6 Phase ...

Initial data are expected in 2027. That timeline is worth noting: a roughly 18-month window from first dose to first readout is a normal pace ...

A Study of SHY-ONC6, a Novel Proteasome Inhibitor, in ...

This is a Phase 1, first-in-human (FIH), open-label, multicenter study designed to evaluate the safety, tolerability, PK, and preliminary ...

SHY Therapeutics Announces the First Patient Has Been ...

Preclinical studies of SHY-ONC6 have demonstrated robust anti-tumor activity and favorable tolerability in multiple in vivo models of solid ...

SHY Therapeutics Announces the First Patient Has Been ...

Preclinical studies of SHY-ONC6 have demonstrated robust anti-tumor activity and favorable tolerability in multiple in vivo models of solid ...

NCT07705334 SHY-ONC6 Clinical Trial Landscape 2026

This is a Phase 1, first-in-human (FIH), open-label, multicenter study designed to evaluate the safety, tolerability, PK, and preliminary anti- ...

NCT07705334 SHY-ONC6 Clinical Trial Landscape 2026

This is a Phase 1, first-in-human (FIH), open-label, multicenter study designed to evaluate the safety, tolerability, PK, and preliminary anti- ...