RBS2418 for Colorectal Cancer
(VISTA-1 Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Riboscience, LLC.

Must not be taking: Chemotherapy, Immunotherapy, others

Disqualifiers: Rapid progression, Other malignancies, others

Prior Safety Data

Trial Summary

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).

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.

Research Team

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)

I am 18 years old or older.

My colorectal cancer diagnosis is confirmed by lab tests.

See 1 more

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.

Trial 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 (Immune Modulator)

Trial OverviewThe 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

4Treatment groups

Active Control

Placebo Group

Group I: Group A: EG+ [ENPP1 and cGAS(Cyclic GMP-AMP synthase) positive] RBS2418 plus Best Supportive CareActive Control1 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 CareActive Control1 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 CarePlacebo Group1 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 CarePlacebo Group1 Intervention

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