Recruiting
Phase 1

R-5780 with PD-1

Sponsor:

Rise Therapeutics LLC

Code:

NCT06398418

Conditions

Solid Tumor, Adult

Solid Tumor

Melanoma

Basal Cell Cancer

Squamous Cell Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

R-5780

Study Details

Brief 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.

Conditions

Solid Tumor, Adult

Solid Tumor

Melanoma

Basal Cell Cancer

Squamous Cell Cancer

Study ID

NCT06398418

Start date

Aug 1, 2025

Status verified date

Sep, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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.

Study Design

Enrollment

33 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Open Label

R-5780 Probiotic

Interventions

R-5780

Probiotic

Primary outcome measure

  • Incidence and severity of adverse events and their relationship to R-5780 (probiotic) administration [ Time Frame: Baseline through Week 4 ]

Central Contacts and Locations

Central contacts

Janet Stephens, PhD

650-417-8556jstephens@risetherapeutics.com

Christian Freguia, PhD

215-923-1818cfreguia@risetherapeutics.com

Locations

Sarah Cannon Research Institute

Recruiting

Denver, Colorado, United States, 80218

Contacts

Tamara Davidson

720-667-7459Tamara.Davidson@sarahcannon.com

Principal Investigator:

Gerald Falchook, MD

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Sam Howell

615-478-2104sam.howell@scri.com

Principal Investigator:

Benjamin Garmezy, MD

More Information

Sponsor

Rise Therapeutics LLC

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Solid Tumors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rise Therapeutics LLC on 2026-09-04.