R-5780 + PD-1 Inhibitors for Solid Tumors

Overseen By Christian Freguia, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Rise Therapeutics LLC

Must be taking: PD-1 inhibitors

Must not be taking: Broad-spectrum antibiotics, Immunosuppressives

Disqualifiers: Severe chronic diseases, Transplants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

33 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new oral probiotic, R-5780, is safe and tolerable for individuals with certain advanced solid tumors, such as unresectable stage III or IV melanoma, who are already receiving a PD-1 inhibitor. The trial focuses on those whose cancer has progressed despite previous treatments. Ideal candidates have experienced cancer progression after at least two cycles of immune therapy or within six months of starting such therapy. Participants should not have active viral infections or more than four prior cancer treatments. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial requires that you stay on your current PD-1 inhibitor medication. However, you cannot take other cancer medications during the trial period.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that R-5780, an oral probiotic, is under study to determine its safety and tolerance in people with solid tumors. Scientists are examining whether it causes side effects or issues when combined with PD-1 inhibitors, drugs that help the immune system fight cancer.

Detailed information on how people handle R-5780 isn't available yet, as the study is in its early stages. This phase primarily assesses the treatment's safety for humans. So far, the FDA has allowed the trial to continue, indicating no major safety concerns in initial tests.

For those considering joining this trial, understanding how the body reacts to new treatments is a key focus. This trial offers an opportunity to help researchers learn more about the safety of this probiotic when used with cancer treatments. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for solid tumors work by using chemotherapy or targeted therapies to attack cancer cells. But R-5780 is different because it is a probiotic treatment, which means it uses beneficial bacteria to help fight cancer. This unique approach could enhance the body's immune response when used alongside PD-1 inhibitors, potentially improving their effectiveness. Researchers are excited because this could lead to fewer side effects and a more natural way to support the body in battling tumors.

What evidence suggests that R-5780 might be an effective treatment for solid tumors?

Research shows that R-5780, a type of probiotic, can activate the immune system. This activation might enhance the effectiveness of certain cancer treatments, known as immune checkpoint inhibitors, by aiding the immune system in attacking cancer cells. Studies have found that R-5780 interacts with the body's microbiome (the collection of tiny organisms living in the body) to support this process. Although most current information comes from early research, promising results suggest it could help treat solid tumors. Participants in this trial will receive R-5780 to evaluate its effectiveness in combination with PD-1 inhibitors for solid tumors. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for patients with certain advanced cancers (like melanoma, basal cell carcinoma, squamous cell carcinoma) who haven't responded to immune checkpoint inhibitors. They should be able to perform daily activities with ease or with some limitations and have a life expectancy of over 3 months. Their cancer must be measurable by scans or visible to the doctor.

Inclusion Criteria

I can sign and understand the consent form.

My doctor expects me to live more than 3 months.

My skin cancer is at an advanced stage and cannot be surgically removed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an oral dosage of probiotic (R-5780) in combination with a PD-1 pathway checkpoint inhibitor. Blood and fecal evaluations of inflammation and assessment of probiotic on fecal levels will be measured.

4 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and quality of life.

16 weeks

Monthly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• R-5780

Trial Overview The study tests R-5780, an oral probiotic, in combination with PD-1 pathway checkpoint inhibitors—drugs that help the immune system recognize and attack cancer cells—in patients with various solid tumors.

How Is the Trial Designed?

Group I: Open Label Experimental Treatment 1 Intervention

R-5780 Probiotic

Who Is Running the Clinical Trial?

Rise Therapeutics LLC

Lead Sponsor

Trials

5

Recruited

180+

Citations

1. targetedonc.com targetedonc.com/view/fda-clears-novel-cancer-immunotherapy-r-5780-for-early-stage-trial

FDA Clears Novel Cancer Immunotherapy R-5780 for ... R-5780 has shown significant potential to activate immune pathways that augment the effectiveness of immune checkpoint inhibitors. The agent ...

2. cancernetwork.com cancernetwork.com/view/fda-clears-investigational-new-drug-application-for-r-5780-in-solid-tumors

FDA Clears Investigational New Drug Application for R ... The RISE R-5780-01 trial will evaluate the safety and tolerability of R-5780 in patients with melanoma, basal cell carcinoma, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06398418?locStr=United+States&country=United+States&aggFilters=status%3A

R-5780-01 In Combination With PD-1 Checkpoint Inhibitors ... The goal of this study is determine the safety and tolerability of orally taken probiotic (R-5780) in patients currently on a PD-1 Pathway Checkpoint Inhibitor ...

4. reporter.nih.gov reporter.nih.gov/project-details/10596291

Project Details - NIH RePORTER R-5780 is based on a unique enzyme known as secreted antigen A (SagA) identified from Enterococcus faecium which our research team showed can engage microbiome- ...

5. risetherapeutics.com risetherapeutics.com/news/70-rise-therapeutics-receives-fda-ind-clearance-to-initiate-clinical-testing-of-r-5780-in-cancer

Rise Therapeutics Receives FDA IND Clearance to Initiate ... R-5780 has demonstrated a pronounced ability to engage immune pathways that enhance the effectiveness immune checkpoint inhibitor therapy. This ...

6. ctv.veeva.com ctv.veeva.com/study/r-5780-01-in-combination-with-pd-1-checkpoint-inhibitors-checkpoint-protein-on-immune-cells-called

R-5780-01 In Combination With PD-1 Checkpoint Inhibitors ... The goal of this study is determine the safety and tolerability of orally taken probiotic (R-5780) in patients currently on a PD-1 Pathway ...