A New Investigational Treatment for Advanced Solid Cancers
SHY-ONC6 is an investigational oral medicine SHY Therapeutics invented and is now studying in adults whose cancer has come back, has spread, or is no longer responding to standard treatments.
This study is called Luca-1. The United States Food and Drug Administration (FDA) requires all new potential cancer treatments to be tested in clinical trials like Luca-1 to learn if they are safe and effective before they can be approved for use.
Volunteers make essential trials like Luca-1 possible. SHY recognizes that the time patients and their families dedicate to considering and possibly participating in Luca-1 is precious. We are deeply grateful to anyone who considers taking part in clinical trials. We encourage you to talk openly with your oncologist about all your options — including other clinical trials, standard treatments, and supportive care.
Luca-1 is the first time SHY-ONC6 is being given to people. As required by the FDA, Luca-1 is designed primarily to study how safe SHY-ONC6 is and, if signs of benefit are seen in the trial, to help determine dosing for subsequent studies that will focus more on its clinical effects. Laboratory and animal studies suggest SHY-ONC6 may be able to slow or shrink certain types of cancers.
We hope SHY-ONC6 will help people who participate in Luca-1, but we cannot promise it will.
Important: The FDA has authorized SHY to conduct the Luca-1 trial to study SHY-ONC6 in people, but SHY-ONC6 has not been approved by the FDA or any other regulatory agency as a drug. Like all cancer medicines being tested for the first time, it may cause side effects, some of which could be serious.
Who might be right for Luca-1?
Luca-1 may be an option for adults who:
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Have an advanced or metastatic solid tumor(s) — meaning a cancer that has come back, spread or cannot be removed by surgery
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Have already tried standard treatments, or for whom standard treatments are not a good option
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Are generally well enough to be active during most of the day
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Have one of the following types of cancer: breast cancer, colon cancer, gastric (stomach) cancer, liver cancer, lung cancer, mesothelioma, pancreatic cancer, prostate cancer, and soft-tissue sarcoma. Other cancer types may be considered on a case-by-case basis.
Condition
Advanced or metastatic solid tumors
Age
At least 18 years of age or older
General Health Status
No serious conditions related to heart, kidneys, or lungs
Availability
2 - 5 days per month
Only a patient's doctor and study team can decide whether Luca-1 is a good fit.
What Would Taking Part Involve?
If you join Luca-1, here is what you can generally expect.
1
The medicine.
SHY-ONC6 is a tablet you swallow. You would take it once a day, on an empty stomach. Each treatment cycle (a repeating block) is 21 days, and you can keep taking it for as long as it is helping you and you are tolerating it well.
2
Clinic visits.
The first cycle has the most visits. You will spend extended time at the clinic on the first day so the team can carefully monitor you, and you will come back several times during the first few weeks for blood tests, heart tracings (ECGs), and check-ins. After the first couple of cycles, visits are less frequent — usually once every three weeks.
3
Tests and procedures.
Throughout the study you will have regular blood draws, physical exams, ECGs, eye exams (at certain points, to watch for possible eye-related changes), and imaging scans (CT, MRI, or PET) about every six weeks at first. The team will also collect a small tumor sample if it is safely possible.
4
Cost.
There is no charge to you for SHY-ONC6 or for the study-specific tests and procedures. Some sites may help with travel costs — ask the study team at your site.
5
Your choice, always.
Taking part is completely voluntary. You can stop at any time, for any reason, without affecting your regular medical care.
Possible Benefits & Possible Risks
We hope SHY-ONC6 will slow or shrink cancer, but we cannot promise that. Some people in early studies of new cancer drugs do benefit; many do not. Even if SHY-ONC6 does not personally help you, what we learn from your participation may help future patients.
We have tested SHY-ONC6 in animals to identify possible SHY-ONC6 side effects but, since this is the first study of SHY-ONC6 in people, we do not yet know what its side effects in humans will be. Side effects could include things like fatigue, nausea, vomiting, diarrhea, changes in blood counts, changes in liver tests, or eye-related changes. Some side effects could be serious. The site study team will monitor you closely and adjust or pause treatment if needed.
The full list of known and possible risks will be explained to you in detail in a written informed consent form before you decide whether to join. Take your time with it. Bring it home, share it with family, and ask as many questions of your doctor and the site study team as you need.
Where is the Study Being Conducted?
SHY expects Luca-1 will be conducted at up to eight cancer centers across the United States. The most current list of participating sites, including addresses and contact information, is maintained on ClinicalTrials.gov, the official U.S. government registry of clinical trials.
To find a site near you: Visit ClinicalTrials.gov and search for SHY-ONC6 or the study identifier SHY-ONC6-101. Each listed site has a contact person and phone number for trial inquiries.
ClinicalTrials.gov is the best place to get up-to-date information about which sites are open, who to call, and which cancer types each site is currently enrolling.
Questions to Ask Your Doctor
If you are thinking about Luca-1, or any clinical trial, here are some questions worth bringing to your appointment, in addition to any others you may have:
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Is this study a reasonable option for me, given my type of cancer and my overall health?
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What treatments would I be choosing between if I joined?
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What would I need to do, and how often would I need to travel to the study site?
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What are the possible side effects, and how would they be managed?
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What happens if the treatment isn’t working, or if I want to stop?
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Will my regular oncologist stay involved in my care?
SHY-ONC6 is an investigational drug and has not been approved by the U.S. Food and Drug Administration or any other regulatory authority. This page is provided for general informational purposes only and is not medical advice. Only a qualified physician can determine whether a clinical trial is appropriate for an individual patient.