CatalYm is committed to advancing visugromab for people living with cancer and their families who are in need of new treatment options. This page provides answers to frequently asked questions (FAQs) about our ongoing clinical trials.
We encourage you to review this information with your treating physician/healthcare provider.
Visugromab is an investigational antibody candidate designed to bind and thereby block the function of Growth Differentiation Factor-15 (GDF-15).
GDF-15 is a molecule secreted by tumor cells into their surrounding environment, which reduces the activity and function of immune cells. Thereby, GDF-15 makes it harder for the immune system to recognize and attack tumor cells. This so-called “immunosuppressive microenvironment” is a key factor that helps tumor cells to become resistant against a range of cancer therapies, including immunotherapies that aim to activate the patient’s immune cells against the tumor.
Beyond its role in reducing immune cell activity, GDF-15 is also known to drive a severe, cancer-associated condition called cachexia. Cachexia is characterized by nausea (the feeling you get when you are about to throw up), vomiting, loss of appetite and involuntary weight loss, particularly of muscle mass.
By blocking the function of GDF-15, visugromab aims to stop the suppression of the immune cells at the tumor site to reactivate an efficient anti-tumor response and ease cachexia symptoms with the goal of improving the patient’s health-related quality of life and ability to tolerate the treatment. Through this multi-layered approach, CatalYm aims to significantly improve clinical results for patients with difficult-to-treat solid tumors who urgently need new therapeutic options.
Clinical trials are carefully designed research studies that go through several phases where patients test new medical approaches (such as drugs or devices like pacemakers) to determine whether they are safe and effective. In most countries, regulatory authorities (governmental health agencies, e.g. the EMA in the EU or FDA in the US) typically require Phase 1, 2 and 3 trials to be completed to determine if the drug or device can be approved for wider use. If researchers find the drug candidate to be safe and effective (working well) after the first three phases, the country’s regulatory authority approves it for clinical use and continues to monitor its effects.
Each phase has a different purpose
Phase 1
A Phase 1 trial tests an experimental drug on a small group of patients (around 20 to 80) to judge its safety, including any side effects, and to test the amount (dosage).
Phase 2
A Phase 2 trial includes more patients (around 100 to 300) to help determine whether a drug is effective. This phase aims to obtain early data on whether the drug works in people who have a certain disease or condition. These trials also continue to examine safety, including short-term side effects.
Phase 3
A Phase 3 trial gathers additional information from several hundred to a few thousand patients about safety and effectiveness (how well a drug works), studying different populations and different dosages and comparing the experimental drug with other drugs or treatment approaches. If a country’s regulatory authority agrees that the trial results support the use of an experimental drug for a particular health condition, it will approve it for clinical use.
Here’s what typically happens in a clinical trial
Trial explained and questions answered
The clinical trial team explains the trial in detail, answers your questions and gathers more information about you and your current health status.
Before you decide whether to take part in a clinical
trial, you will receive detailed information about
the trial. This process is called informed consent.
The informed consent document explains the purpose
of the trial, what participation involves, potential
benefits and risks, and your rights as a participant.
Members of the study team will review this information
with you and answer any questions you may have.
Once you agree to participate, you sign an informed consent form indicating your understanding about what to expect as a participant and the various outcomes that could occur. Taking part in a clinical trial is entirely voluntary. Even after joining a clinical trial, you can choose to opt out at any time without affecting your regular medical care.
Screening tests
You undergo screening tests to make sure you qualify for the trial.
Baseline visit
If accepted into the trial, you schedule a first visit, called the “baseline” visit. The clinical trial team conducts cognitive (memory and thinking) and/or physical tests during this visit.
Randomization in some trials
For some trials, you are assigned by chance (randomly) to a treatment group or a control group. The treatment group will get the experimental drug being tested and the control group will not; they may receive a placebo instead.
Follow procedures and report issues
You follow the trial procedures and report any issues or concerns to the clinical trial team.
Regular follow-up visits
You may visit the clinical trial site at regularly scheduled times for new cognitive, physical or other evaluations and discussions with staff. During these visits, the clinical trial team collects data and monitors your safety and well-being.
Continue regular physician care
You continue to see your regular physician(s) for usual health care throughout the trial.
Clinical trials often test how a drug candidate works in people with a specific condition. Because each trial is designed for a particular group of patients, not everyone will meet the criteria to participate in every trial.
✓ Inclusion criteria
To be able to participate, you need to have certain characteristics, called inclusion criteria. For example, a clinical trial may need participants to have a certain type or stage of disease.
× Exclusion criteria
Patients with certain characteristics may not be allowed to participate in some trials. These characteristics are called exclusion criteria. They include factors such as specific health conditions or medications that could interfere with the treatment being tested.
If you are interested in participating in one of CatalYm’s clinical trials, please talk to your treating physician/healthcare provider.
For Healthcare Professionals
Healthcare professionals are key partners in advancing clinical research and helping bring innovative treatment options to patients in need. To learn more about our ongoing clinical trials, study eligibility criteria and participating sites, please visit ClinicalTrials.gov.