RBS2418 for Colorectal Cancer

(VISTA-1 Trial)

Recruiting at 4 trial locations

Overseen By Riboscience Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Riboscience, LLC.

Must not be taking: Chemotherapy, Immunotherapy, others

Disqualifiers: Rapid progression, Other malignancies, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called RBS2418 for individuals with advanced, metastatic colorectal cancer (CRC) that has worsened despite standard treatments. RBS2418 aims to enhance the immune system's ability to fight cancer. Participants will receive either RBS2418 or a placebo (a non-active substance) along with the best supportive care. The study seeks individuals with a confirmed diagnosis of colorectal cancer that has progressed and is unresponsive to other treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you stop any approved anti-cancer therapy, including chemotherapy, targeted therapy, or immunotherapy, at least 2 weeks before starting the study treatment. However, hormone-replacement therapy or oral contraceptives are allowed.

Is there any evidence suggesting that RBS2418 is likely to be safe for humans?

Research has shown that RBS2418 has been well-tolerated in earlier studies. One study found RBS2418 to be very safe, even at higher doses, without causing severe side effects, suggesting it is generally safe for patients. Another study found that RBS2418, whether taken alone or with another drug, was safe and tolerable at all tested doses. These findings indicate that RBS2418 is unlikely to cause serious side effects in people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for colorectal cancer?

RBS2418 is unique because it specifically targets ENPP1 and cGAS, proteins involved in cancer cell survival and immune system evasion. Unlike traditional colorectal cancer treatments like chemotherapy, which broadly attack rapidly dividing cells, RBS2418 aims to boost the immune system's ability to recognize and destroy cancer cells by focusing on these specific pathways. Researchers are excited about this targeted approach because it could offer a more precise treatment with potentially fewer side effects, making it a promising option for patients whose cancer cells express these proteins.

What evidence suggests that RBS2418 might be an effective treatment for colorectal cancer?

Research has shown that RBS2418, a medicine that aids the immune system, targets a protein called ENPP1 to enhance the body's tumor-fighting ability. Early studies have found that RBS2418 is safe and may reduce tumor size in various cancers, including colorectal cancer. In this trial, participants in Group A and Group C will receive RBS2418 plus Best Supportive Care. A study with patients who had advanced cancers found that RBS2418 was well-tolerated and showed promise, even for those unresponsive to other treatments. This suggests that RBS2418 could be a hopeful option for people with advanced colorectal cancer. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with advanced, metastatic, and progressive colorectal cancer. Participants should not have had previous treatments that conflict with the trial or health issues that could interfere with the study.

Inclusion Criteria

Willing to submit a pre-treatment tissue sample (archival, or fresh tissue if archival is not available)

My colorectal cancer diagnosis is confirmed by lab tests.

I have advanced colorectal cancer and can't use standard treatments anymore.

Exclusion Criteria

My condition worsened quickly after previous treatments.

I haven't had cancer treatment in the last 2 weeks and have recovered from any side effects.

I haven't had any other cancers in the last 3 years, except for low-risk ones treated with a curative intent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RBS2418 or placebo plus Best Supportive Care in 21-day cycles up to two years or until disease progression, death, withdrawal, or study completion

Up to 2 years

Follow-up

Participants are monitored for adverse events and serious adverse events after treatment

Up to 90 days

What Are the Treatments Tested in This Trial?

Interventions

• RBS2418

Trial Overview The study tests RBS2418, a drug aiming to boost immune response against cancer by preventing breakdown of a molecule involved in activating immune cells. It's compared to a placebo to see if it's safe and effective in treating colorectal cancer.

How Is the Trial Designed?

Group I: Group A: EG+ [ENPP1 and cGAS(Cyclic GMP-AMP synthase) positive] RBS2418 plus Best Supportive Care Active Control 1 Intervention

RBS2418: 200 mg (2 RBS2418 capsules), PO (by mouth), BID (twice a day) plus Best Supportive Care

Group II: Group C: EG- (ENPP1 and/or cGAS negative) RBS2418 plus Best Supportive Care Active Control 1 Intervention

RBS2418: 200 mg (2 RBS2418 capsules), PO, BID plus Best Supportive Care

Group III: Group B: EG+ (ENPP1 and cGAS positive) Placebo plus Best Supportive Care Placebo Group 1 Intervention

Placebo: 2 placebo capsules, PO, BID plus Best Supportive Care

Group IV: Group D: EG- (ENPP1 and/or cGAS negative) Placebo plus Best Supportive Care Placebo Group 1 Intervention

Placebo: 2 placebo capsules, PO, BID plus Best Supportive Care

Who Is Running the Clinical Trial?

Riboscience, LLC.

Lead Sponsor

Trials

3

Recruited

210+

Tam Anh Research Institute

Collaborator

Trials

3

Recruited

3,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06824064

Study Details | NCT06824064 | Evaluation of RBS2418 in ... The hypothesis is that RBS2418 versus placebo will be generally safe, well-tolerated, immunogenic, and will lead to anti-tumor responses in adult subjects for ...

2. trialx.com trialx.com/clinical-trials/listings/319229/evaluation-of-rbs2418-in-patients-with-advanced-metastatic-and-progressive-colorectal-cancer/

Clinical Research Trial Listing ( Advanced Colorectal Cancer The hypothesis is that RBS2418 versus placebo will be generally safe, well-tolerated, immunogenic, and will lead to anti-tumor responses in adult subjects for ...

3. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/e/NCT05270213.html

Evaluation of RBS2418 in Subjects With Advanced, Metastatic ... RBS2418 has the potential to be an important therapeutic option for subjects both as monotherapy and in combination with other cancer treatments including ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06824064?term=AREA%5BInterventionSearch%5D(rbs2418)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=2

Evaluation of RBS2418 in Patients with Advanced, ... The hypothesis is that RBS2418 versus placebo will be generally safe, well-tolerated, immunogenic, and will lead to anti-tumor responses in adult subjects for ...

5. trial.medpath.com trial.medpath.com/news/84045819ebfc4cb9/riboscience-s-first-in-class-enpp1-inhibitor-rbs2418-shows-promising-safety-and-efficacy-in-phase-1a-cancer-trial

Riboscience's First-in-Class ENPP1 Inhibitor RBS2418 Shows ... The study enrolled 24 patients with advanced solid tumors across 13 cancer types, with 83% having failed three or more prior treatment lines, showing target- ...

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(23)03001-6/fulltext

1025MO Preliminary safety, pharmacokinetics and ... RBS2418, a first-in-class oral ENPP1 inhibitor, is in an ongoing phase I clinical trial in solid tumors. Methods. Phase 1 dose escalation (3+3 design) with 100, ...

7. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/575756

Evaluation of RBS2418 in Patients with Advanced ... The hypothesis is that RBS2418 versus placebo will be generally safe, well-tolerated, immunogenic, and will lead to anti-tumor responses in ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2597

Correlation of baseline ENPP1 and cGAS expression in ... Conclusions: Oral RBS2418 alone or with pembrolizumab has been safe, well tolerated with no DLTs at all dose levels evaluated to date in the ...