RBS2418 for Colorectal Cancer

(VISTA-1 Trial)

Recruiting at 2 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

Trial Summary

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.

What is the purpose of this trial?

RBS2418 is a specific immune modulator that works through the inhibition of ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) and is designed to lead to anti-tumor immunity by protecting endogenous 2'-3'-cyclic guanosine monophosphate-adenosine monophosphate (cGAMP) from hydrolysis and leading to the activation of antigen-presenting cells followed by T cell activation. 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 the treatment of advanced, metastatic, and progressive colorectal cancer (CRC).

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+