RecruitingPHASE1INTERVENTIONAL

Study of Safety and Efficacy of RGT-61159 in Adults With Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)

This study, called a Phase 1 trial, is looking at a new medicine called RGT-61159. It's for adults who have advanced adenoid cystic carcinoma (a rare cancer often of the head and neck) or colorectal cancer (bowel cancer). These are people whose cancer has come back or spread and who have already tried other treatments that are no longer working, or who can’t have the usual treatments. The main goals of this study are to find out two things: first, if RGT-61159 is safe and how well people can tolerate it, and second, if it can help stop the cancer from growing or even shrink the tumors. By joining, patients would be among the first to try this new drug.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Rgenta Therapeutics Inc

Enrolment target

105

Start

19 Aug 2024

Estimated completion

01 Jun 2027

Adenoid Cystic Carcinoma Colorectal Cancer

What is this study about?

This study is an early-stage clinical trial, known as a Phase 1 study. This means it's one of the very first times this new medicine, RGT-61159, is being tested in people. The main purpose is to check if the drug is safe to use and how well people tolerate it, meaning what side effects they might experience. This is crucial step before the drug can be tested more widely.

The study is for adults whose cancer has either returned (relapsed) or spread to other parts of the body (advanced/metastatic), and who have exhausted standard treatment options. This includes two specific types of cancer: adenoid cystic carcinoma (ACC) and colorectal cancer (CRC). ACC is a relatively rare type of cancer, often affecting glands in the head and neck area, while CRC is a common type of bowel cancer.

RGT-61159 is designed to work by targeting a specific protein called MYB, which plays a role in how cancer cells grow. By blocking this protein, the drug aims to slow down or stop the cancer from growing. Patients in this study will take RGT-61159 as a tablet once a day. Researchers will closely monitor their health and check if their tumors respond to the treatment.

Key takeaways

This is an early-stage study (Phase 1) of a new cancer drug called RGT-61159.
It aims to check the safety and initial effectiveness in advanced ACC or CRC.
The drug is taken as a daily tablet.
It's for people whose cancer has returned or spread, and who have limited other treatment options.
Patients will be closely monitored for side effects and how their cancer responds.
Participation is voluntary, and you can leave the study at any time.

Who may be eligible?

To join this study, adults must have been diagnosed with either adenoid cystic carcinoma (ACC) or colorectal cancer (CRC) that has come back or spread, and where surgery or radiation isn't a cure. For ACC patients, your cancer must have shown signs of growth or spread within the last year. For CRC patients, you must have already tried or can't have standard treatments like certain chemotherapies.

You also need to have parts of your cancer that can be measured on scans. Your body's organs, like your kidneys, liver, and blood, need to be working well. Any side effects from previous treatments must have mostly cleared up before you start.

There are some reasons why you might not be able to join. For example, if you've had major surgery or recent chemotherapy/radiation within a few weeks of starting the study, or if you have an active serious infection. Having certain heart conditions or active cancer elsewhere in your body would also mean you can't take part. However, well-managed HIV might be acceptable.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have advanced ACC or CRC that has returned or spread?
Do I have measurable cancer on scans?
Have I tried or can I not have standard treatments for my cancer type?
Are my kidneys, liver, and blood counts generally healthy?
Have I recovered from any recent surgery or previous cancer treatments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the study drug, RGT-61159, to take as a tablet once a day. You will have regular visits to the hospital or clinic so the study team can monitor your health, check for any side effects, and see how well the treatment is working. These visits will involve physical examinations, blood tests, and imaging scans (like CT or MRI) to measure your cancer.

The study may last for several months or longer, depending on how you respond to the treatment and whether you experience any side effects. You will be closely followed throughout the study and for some time afterwards to track your health. The total duration of your participation will be explained in detail by the study team.

Potential risks and benefits

Taking part in a new drug study like this means you might be among the first to receive a potentially helpful new treatment for your cancer, especially if your current options are limited. However, like all medicines, RGT-61159 may have side effects, some of which might be serious or unknown. The study team will closely monitor you for any problems. You will always have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

Dana-Farber Cancer Institute
Verified postcode
Boston, United States· Recruiting
University of Michigan
Verified postcode
Ann Arbor, United States· Recruiting
Washington University School of Medicine
Verified postcode
St Louis, United States· Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
Verified postcode
New York, United States· Recruiting
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States· Recruiting
MD Anderson Cancer Center
Verified postcode
Houston, United States· Recruiting
Next Oncology VA
Verified postcode
Fairfax, United States· Recruiting
Fred Hutchinson Cancer Center
Verified postcode
Seattle, United States· Recruiting
Ottawa Hospital Cancer Centre
Verified postcode
Ottawa, Canada· Recruiting
Princess Margaret Cancer Center
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is a 'Phase 1' study?

A Phase 1 study is the first stage of testing a new drug in people. Its main goal is to find out if the drug is safe and what dose can be given, rather than how well it treats the disease.

What types of cancer is this study for?

This study is specifically for adults with advanced adenoid cystic carcinoma (ACC) or colorectal cancer (CRC) that has come back or spread.

How will I take the study drug?

The study drug, RGT-61159, is an oral medication, meaning you will take it as a tablet, most likely once a day.

Will I receive other cancer treatments while on this study?

Generally, you will not receive other cancer treatments at the same time as the study drug. The study has specific rules about when you can join after previous treatments.

What does 'relapsed/refractory' mean?

It means your cancer has come back after treatment ('relapsed') or has not responded to previous treatments, or has stopped responding ('refractory').

How to find out more

Clinical Operations

clinical-operations@rgentatx.com 857-225-2840 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.