Solid Tumor, AdultPhase 1NCT06398418
R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors
A Phase 1 study testing R-5780 in people with Solid Tumor, Adult and Solid Tumor, run by Rise Therapeutics LLC at 2 sites in United States.
Trial summary
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 (checkpoint protein on immune cells called T cells) with Solid Tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumor, Adult, Solid Tumor, Melanoma
- What is being tested?
- R-5780
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2025to 15 Sep 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age to 80
- Ability to provide written informed consent
- Unresectable stage III or stage IV melanoma, basal cell carcinoma, or squamous cell carcinoma as per the American Joint Committee on Cancer 2017 Guidelines (8th Edition) regardless of BRAF mutation status and other solid tumors.
- Refractory to anti-PD (checkpoint Protein on Immune Cells called T cells)-1/L1 therapy per RECIST v1.1 defined as subject who has disease progression after receiving at least two complete cycles of ICI (immune checkpoint inhibitors) therapy or disease progression 6 months from initiation of ICI (immune checkpoint inhibitors) therapy while still on active therapy.
- Life expectancy of greater than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Subjects must have evaluable disease by CT (computer tomography) or MRI (magnet resonance imaging) per RECIST 1.1 criteria or clinically apparent disease that the investigator can follow for response.
Who cannot join
- Any serious medical condition or laboratory abnormality or psychiatric condition or any other significant or unstable concurrent medical illness (in the opinion of the Investigator) would preclude protocol adherence or would make the safety of the study drug difficult to assess
- Treatment with systemic broad-spectrum antibiotics.
- No active viral infections.
- Coexisting severe chronic diseases other than cancer (autoimmunity, inflammatory diseases)
- Secondary gastrointestinal motility disorders
- History of solid organ transplant or bone marrow transplant
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- Prior CAR-T (chimeric antigen receptor) or allogeneic cellular therapy
- Ongoing systemic immunosuppressive therapy, with the exclusion of prednisone (10 mg/day)
- Concurrent therapy with any other investigational agent, vaccine, or device
- Pregnant or breastfeeding or planning to conceive or father a child during the trial period
- Subjects with untreated brain metastasis. Treated brain metastasis are permitted if stable
- More than 4 prior systemic therapies
- Other cancer medications during treatment period are not permitted
- Enrollment in other clinical trials.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Sarah Cannon Research Institute
Denver, Colorado, 80218
Tamara Davidson, 720-667-7459, Tamara.Davidson@sarahcannon.com
Gerald Falchook, MD
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Sam Howell, 615-478-2104, sam.howell@scri.com
Benjamin Garmezy, MD
About this study
Official title: A Single and Repeat Dosing and Expansion Study of the Safety, Drug Exposure and Clinical Activity of R-5780 in Combination With a PD-1 (Checkpoint Protein on Immune Cells Called T Cells) Pathway Checkpoint Inhibitor in Patients With Solid Tumors
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 (checkpoint protein on immune cells called T cells) with Solid Tumors.
Read the detailed description
Patients will take an oral dosage of probiotic (R-5780 and provide patient reported overall feeling and physician scored measure of their tumors. Blood and fecal evaluations of inflammation and assessment of probiotic (R-5780) on fecal levels will also be measured.
- Conditions
- Solid Tumor, Adult, Solid Tumor, Melanoma, Basal Cell Cancer, Squamous Cell Cancer, Adenoma
- Being tested
- R-5780
- Keywords
- Solid Tumors
- Medical subject headings
- Melanoma, Neoplasms, Basal Cell, Neoplasms, Squamous Cell, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-5780Drug
Probiotic
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Other | R-5780 Probiotic Receives: Drug: R-5780 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events and their relationship to R-5780 (probiotic) administration
To assess the number of participants with treatment-related adverse events after taking R-5780 (probiotic)
Measured: Baseline through Week 4
Secondary outcomes (1)
Scale (QOLS)
Collect how the patient is feeling on each study visit on the Quality of Life Scale of 30 questions. The Quality of Life scores are summed so that a higher score indicates higher quality of life.
Measured: Baseline through End of Study Day 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 Aug 2025
- Primary completion15 Mar 2029 (estimated)
- Study completion15 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rise Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398418
- Sponsor's protocol ID
- RISE R-5780-01
- Status last verified
- Sep 2026
- First submitted
- 29 Apr 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single and Repeat Dosing and Expansion Study of the Safety, Drug Exposure and Clinical Activity of R-5780 in Combination With a PD-1 (Checkpoint Protein on Immune Cells Called T Cells) Pathway Checkpoint Inhibitor in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT06398418
- Acronym / sponsor ID
- RISE R-5780-01
- Conditions
- Solid Tumor, Adult, Solid Tumor, Melanoma, Basal Cell Cancer, Squamous Cell Cancer, Adenoma
- Keywords
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Rise Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 15 Mar 2029 (estimated)
- Study completion
- 15 Sep 2029 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (checkpoint protein on immune cells called T cells) with Solid Tumors.
Detailed description
Patients will take an oral dosage of probiotic (R-5780 and provide patient reported overall feeling and physician scored measure of their tumors. Blood and fecal evaluations of inflammation and assessment of probiotic (R-5780) on fecal levels will also be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Open Label | Other | Drug: R-5780R-5780 Probiotic |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years of age to 80
- Ability to provide written informed consent
- Unresectable stage III or stage IV melanoma, basal cell carcinoma, or squamous cell carcinoma as per the American Joint Committee on Cancer 2017 Guidelines (8th Edition) regardless of BRAF mutation status and other solid tumors.
- Refractory to anti-PD (checkpoint Protein on Immune Cells called T cells)-1/L1 therapy per RECIST v1.1 defined as subject who has disease progression after receiving at least two complete cycles of ICI (immune checkpoint inhibitors) therapy or disease progression 6 months from initiation of ICI (immune checkpoint inhibitors) therapy while still on active therapy.
- Life expectancy of greater than 3 months
Key exclusion criteria (14 listed)
- Any serious medical condition or laboratory abnormality or psychiatric condition or any other significant or unstable concurrent medical illness (in the opinion of the Investigator) would preclude protocol adherence or would make the safety of the study drug difficult to assess
- Treatment with systemic broad-spectrum antibiotics.
- No active viral infections.
- Coexisting severe chronic diseases other than cancer (autoimmunity, inflammatory diseases)
- Secondary gastrointestinal motility disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R-5780Probiotic | Drug | Open Label |
Primary outcome
Incidence and severity of adverse events and their relationship to R-5780 (probiotic) administration
Time frame: Baseline through Week 4
To assess the number of participants with treatment-related adverse events after taking R-5780 (probiotic)
1 secondary outcome
Scale (QOLS)
Time frame: Baseline through End of Study Day 112
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing R-5780 in people with Solid Tumor, Adult and Solid Tumor, run by Rise Therapeutics LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janet Stephens, PhD (650-417-8556, jstephens@risetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events and their relationship to R-5780 (probiotic) administration (time frame: Baseline through Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.