Visugromab for Cancer-Related Cachexia

(VINCIT Trial)

Overseen By Trial Director

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: CatalYm GmbH

Disqualifiers: Other trials, Investigational therapy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

518 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, visugromab, to determine its effectiveness for people with certain cancers, such as lung or bowel cancer, who experience unintentional weight loss (a condition known as cachexia). Researchers aim to assess whether the drug helps individuals gain weight, improve appetite, and increase activity levels. The trial compares different doses of visugromab to a placebo to evaluate safety and effectiveness. Ideal candidates for the trial are those with advanced cancer experiencing unintended weight loss. Participants will visit the clinic every four weeks for treatment and checkups. As a Phase 2 trial, this research measures how well visugromab works in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you have been in another clinical trial or used an investigational therapy in the last 4 weeks.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that visugromab has promising safety results from earlier studies, which tested it on various difficult-to-treat tumors. Patients generally tolerated the treatment well. Reports indicate that it strengthened the body's immune response against cancer cells without causing serious side effects.

In other research, when combined with another drug called nivolumab, patients responded well over a long period. This combination was also well-tolerated by patients with various cancers, suggesting that visugromab can be a safe option.

While every medication can have some side effects, available data suggest that visugromab is safe for people. Anyone considering joining a trial should discuss potential risks and benefits with their healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Visugromab because it offers a novel approach to tackling cancer-related cachexia, a condition where patients experience severe weight loss and muscle wasting. Unlike traditional treatments that often focus on nutritional support or anabolic steroids, Visugromab works by targeting specific pathways involved in muscle degradation, potentially preserving muscle mass more effectively. This targeted mechanism could lead to better outcomes for patients, providing a new strategy to improve quality of life for those affected by this debilitating condition.

What evidence suggests that visugromab might be an effective treatment for cancer-related cachexia?

Research has shown that visugromab may help cancer patients experiencing cachexia, a condition marked by significant weight and muscle loss. Patients using visugromab have demonstrated improvements in weight gain and appetite. Studies also suggest it might enhance mobility and overall quality of life. Additionally, visugromab has made it easier for patients to tolerate other cancer treatments. These findings highlight its potential as a supportive treatment for those dealing with cancer-related cachexia. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for people with advanced cancer who have experienced significant weight loss, known as cachexia. Ideal candidates are those looking to improve their appetite and physical function.

Inclusion Criteria

I have experienced weight loss.

My cancer is in an advanced stage.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive visugromab or placebo via a drip into a vein every 4 weeks

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Visugromab

Trial Overview

The study tests visugromab (CTL-002) against a placebo to see if it helps patients gain weight, eat better, and move more easily. Participants will receive the treatment through an IV every four weeks while being monitored.

How Is the Trial Designed?

Group I: Visugromab high dose Active Control 1 Intervention

Group II: Visugromab medium dose Active Control 1 Intervention

Group III: Visugromab low dose Active Control 1 Intervention

Group IV: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

CatalYm GmbH

Lead Sponsor

Trials

2

Recruited

300+

Citations

1.

catalym.com

catalym.com/catalym-presents-long-term-phase-1-2a-data-confirming-sustained-responses-with-visugromab-in-cpi-refractory-tumors-at-esmo-2025/

CatalYm Presents Long-Term Phase 1/2a Data Confirming ...

In addition, visugromab also mitigates cancer cachexia, a severe condition affecting a significant number of advanced cancer patients by ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07112196

NCT07112196 | Visugromab in Cachexia International Trial

A study of how well and safely a new drug called visugromab works in people with certain kinds of cancer (including lung and bowel cancer) and unintended weight ...

3.

targetedonc.com

targetedonc.com/view/visugromab-plus-nivolumab-shows-durable-response-in-refractory-tumors

Visugromab Plus Nivolumab Shows Durable Response in ...

Visugromab combined with nivolumab showed a median duration of response exceeding 2 years in refractory NSCLC, UC, and HCC patients. GDF-15 is a ...

4.

biospace.com

biospace.com/press-releases/catalym-presents-phase-2-data-in-neoadjuvant-bladder-cancer-demonstrating-substantial-increase-of-anti-tumor-activity-for-visugromab-in-combination-with-pd-1-inhibitor-at-esmo

CatalYm Presents Phase 2 Data in Neoadjuvant Bladder ...

Visugromab combined with PD-1 inhibitor, nivolumab, more than quadrupled the rate of pathological Complete Response (pCR; 33.3% vs.

5.

biogenerationventures.com

biogenerationventures.com/en/news/catalym_announces_first_patient_dosed_in_phase_2b_trial_evaluating_visugromab_in_combination_with_chemoimmunotherapy_as_first_li

CatalYm Announces First Patient Dosed in Phase 2b Trial ...

Visugromab also showed potential to mitigate cancer cachexia, enhancing patients' quality of life and treatment tolerability, which could extend ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11955301/

GDF-15 blockade: Cancer immunotherapy & cachexia

... cancer‐related cachexia. Ponsegromab treatment at doses of up to 400 mg Q4W was very safe and led at the highest dose to significant weight gain ...