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Solid Tumor and Lymphoma Clinical Trial
The DAHLIA clinical trial is an open-label study for people with cancer, with solid tumors and lymphoma.
About the DAHLIA study: An open-label clinical trial for people with solid tumors and lymphoma
The DAHLIA study (NCT06678659) is a Phase 1/2 clinical trial for individuals with certain solid
tumors and lymphoma including cancers with specific genetic changes or "biomarkers". The trial is evaluating the impact of an investigational drug called REC-1245 on clinical efficacy and safety for those living with these specific cancers. Because this is an open-label study, meaning that the research team and you know that you are receiving a study drug, every participant in the trial will receive the active study treatment, REC-1245.
Can I join the DAHLIA study?
You may be eligible to join this solid tumor and lymphoma clinical trial if you meet the following core requirements*:
Age:
You are 18 years of age or older.
Diagnosis:
- You have a confirmed diagnosis of certain types of solid tumors and your cancer has progressed, come back after treatment, or you cannot take or tolerate at least one standard treatment for your cancer type, or
- You have Non-Hodgkin’s lymphoma that has come back after previous treatment, or standard treatments are not suitable for you or are no longer working, or
- Your cancer has certain genetic changes, including solid tumors that are confirmed as MSI and/or dMMR. If you have these changes, your cancer also
needs to have gotten worse, or you cannot receive or cannot tolerate a type of immune-boosting treatment called a checkpoint inhibitor.
*These are the primary criteria. The study site physician will determine your individual eligibility.
A patient journey through the DAHLIA study
Screening for participation eligibility
Trial period
On study drug for up to 2 years
End of treatment visit
Safety follow up visit
30 days after last dose of study drug
Long term follow up
By phone call every 6 months after last dose of study drug
Screening for Participation Eligibility
Baseline Endoscopy
On Treatment
REC-4881—4mg given orally once a day for 12 weeks
Week 13 Endoscopy
Off Treatment
12 weeks off treatment
Week 25 Endoscopy
A clinical trial is meant to study an investigational medication, meaning that neither the safety nor the effectiveness of the drug has been established. Taking part in this study may involve risks that are currently unknown. The known risks of taking part in this study will be explained to you during the informed consent process. If you are considering joining the trial, talk to your doctor about the clinical study. If you are interested in taking part, you will have the chance to
ask questions and learn about these risks, so you can decide if the study is right for you.
Find a study location near you
FAQs
What is the purpose of the DAHLIA clinical trial?
The DAHLIA study is evaluating an investigational drug called REC-1245 to evaluate its impact on clinical outcomes and safety for those living with certain solid tumors and lymphoma. Specific questions the trial will aim to answer are:
- Is REC-1245 safe for patients with cancer and are there any side effects?
- Will REC-1245 show any impact on tumor activity in patients with cancer?
What would exclude me from taking part in the study?
Various factors about your health may exclude you. The following are some criteria specific to this study:
- REC-1245 is one of a class of drugs called “RBM39 degraders” and if you have received treatment with another RBM39 degrader, you may not be able to take part in the study.
- If you have been diagnosed with significant gastrointestinal malabsorption, meaning your small intestine cannot adequately absorb nutrients from the foods you eat, you would not be able to take part in the study.
Does my current cancer treatment need to stop if I join the study?
Yes, some of your current cancer treatment may need to stop to take part in this study in order to understand what impact this investigational drug might have on your cancer. Please consult with the study site for more information.
What does an “open-label” trial mean for me?
In this trial, "open-label" means there is no placebo and all study participants and doctors will know what you are taking. Every person who is eligible and enrolls in the study will receive the active investigational medication, REC-1245.
What is an investigational drug?
An investigational drug (also called an experimental treatment) is a substance that has not been approved by government regulatory agencies, such as the U.S. Food and Drug Administration (FDA), for use by the general public. Its safety and efficacy have not been established.
How is REC-1245 taken?
REC-1245 is an oral medication taken by swallowing a tablet.
How often would I need to visit the research site?
You will visit the research site for the screening visit and the first dosing visit. After that you will return to the research site once every other week for the first 9 weeks, and then once every four weeks for up to 2 years.
How long would I be in the study?
Participation in the study will last approximately 2 years.
Can I take part if I don’t live near a research site?
If you are interested in enrolling in the trial, please contact your nearest study site or contact us to find a site nearest to you. You would then contact that site to discuss your options for participation.
What are the risks of taking part in this trial?
This clinical trial is meant to study an investigational medication, meaning that neither the safety nor the effectiveness of the drug has been established. Taking part in this study may involve risks that are currently unknown. The known risks of taking part in this study will be explained to you during the informed consent process. If you are considering joining the trial, talk to your doctor about the clinical study. If you are interested in taking part, you will have the chance to ask questions and learn about these risks, so you can decide if the study is right for you.
Do I need to pay to take part in the trial or will I be compensated?
You do not need to pay to take part - there is no cost to participate in the DAHLIA study. If you are enrolled in the trial, you will be compensated for your time spent with every visit and reimbursed for certain travel and meal expenses.
Do I need health insurance to take part in the trial?
No health insurance is required to take part in the DAHLIA study.
Can I join other trials while taking part in the DAHLIA solid tumor and lymphoma clinical study?
If you take part in the DAHLIA study, you cannot join another study at the same time where you would receive an investigational drug. You can take part in an observational study (a study where doctors track your health and symptoms over time without changing your treatment or introducing experimental treatments) that does not require you to take an investigational drug from that study.
This product is under investigation and has not been approved by the FDA. The safety and effectiveness of this product has not been established. This information is for informational purposes only and does not constitute medical advice, diagnosis, or treatment. Please consult your doctor or get in touch with the sites.
