SHY-ONC6 for Cancer
(Luca-1 Trial)
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation (Phase 1a)
Participants receive SHY-ONC6 with sequential dose levels evaluated under accelerated titration and BOIN dose-escalation design
Dose Expansion (Phase 1b)
Participants evaluated in disease-specific expansion cohorts and receive SHY-ONC6 at the RP2D range identified in Phase 1a
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Participants receive SHY-ONC6 administered orally once daily. Phase 1a, sequential dose levels are evaluated under accelerated titration and BOIN dose-escalation design. In Phase 1b, participants will be evaluated in disease-specific expansion cohorts and receive SHY-ONC6 at the RP2D range identified in Phase 1a.
Find a Clinic Near You
Who Is Running the Clinical Trial?
SHY Therapeutics
Lead Sponsor
Citations
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. ...
2.
clinicaltrialvanguard.com
clinicaltrialvanguard.com/news/shy-therapeutics-doses-first-patient-in-shy-onc6-phase-1-trial-for-solid-tumors/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 ...
5.
markets.businessinsider.com
markets.businessinsider.com/news/stocks/shy-therapeutics-announces-the-first-patient-has-been-dosed-in-phase-1-clinical-trial-evaluating-shy-onc6-a-novel-oral-proteasome-inhibitor-for-the-treatment-of-solid-tumors-1036405702SHY 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 ...
6.
synapse.patsnap.com
synapse.patsnap.com/blog/clinical-landscape-nct07705334-shy-onc6-trial-report-2026-mcpNCT07705334 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- ...
7.
synapse-patsnap-com.libproxy1.nus.edu.sg
synapse-patsnap-com.libproxy1.nus.edu.sg/blog/clinical-landscape-nct07705334-shy-onc6-trial-report-2026-mcpNCT07705334 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- ...
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