Metastatic Colorectal CancerPhase 2VISTA-1NCT06824064
Evaluation of RBS2418 in Patients With Advanced, Metastatic, and Progressive Colorectal Cancer
A Phase 2 study testing RBS2418 in people with Metastatic Colorectal Cancer and Advanced Colorectal Cancer, run by Riboscience, LLC. at 8 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, Advanced Colorectal Cancer
- What is being tested?
- RBS2418
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 17 Jan 2025to Dec 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age on the day of signing informed consent.
- Male and female subjects with advanced, metastatic, progressive CRC who have received, been ineligible for, intolerant to, or declined all approved standard of care (SOC) therapies for metastatic CRC, as per local SOC treatment regimens. Additionally, subjects must have documented PD based on two scans performed within 2 to 4 months of study initiation.
- Have histologically or cytologically confirmed CRC diagnosis based on pathology report.
- Willing to submit a pre-treatment tissue sample (archival, or fresh tissue if archival is not available).
Who cannot join
- Any approved anti-cancer therapy including chemotherapy, targeted small molecule therapy, systemic immunotherapy, or radiation therapy within 2 weeks prior to the first dose of study treatment; or if subject has not recovered (i.e., ≤ to Grade 1 or returned to baseline level) from AEs due to a previously administered agent; the following exceptions are allowed:
- Palliative radiotherapy for bone metastases or soft tissue lesions should be completed >7 days prior to the first dose of study treatment.
- Hormone-replacement therapy or oral contraceptives.
- Subjects with Grade 2 neuropathy or Grade 2 alopecia.
- Subjects with evidence of rapid progression on prior therapy resulting in rapid clinical deterioration.
- Malignancies other than indications open for enrollment within 3 years prior to Day 1, except for those with negligible risk of metastasis or death treated with expected curative outcome, undergoing active surveillance, or treatment-naïve for indolent tumors.
Trial locations and contacts
8 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 3 countries
United States4 sites, 4 recruiting
- Recruiting
Community Clinical Trials
Kingwood, Texas, 77339
- Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
- Recruiting
SCRI Oncology LLC
Nashville, Tennessee, 37203
- Recruiting
Christiana Care
Newark, Delaware, 19718
Vietnam3 sites, 3 recruiting
- Recruiting
Tam Anh, Ha Noi General Hospital
Hanoi, Hanoi, 10000
- Recruiting
Tam Anh TP. Ho Chi Minh General Hospital
Ho Chi Minh City, Ho Chi Minh City, 70000
- Recruiting
Oncology Hospital
Ho Chi Minh City, 715000
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of RBS2418 Plus Best Supportive Care (BSC) in Subjects With Advanced, Metastatic, and Progressive Colorectal Cancer
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).
Read the detailed description
In this Phase 2a study, subjects must have failed, been unable to tolerate, or declined to take known standard-of-care (SOC) therapies. Subjects must have measurable disease per RECIST 1.1, an Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1 or 2, and predicted life expectancy of greater or equal to 3 months.
Up to approximately 150 subjects will be enrolled and will receive therapy as part of their respective treatment group. Subjects will receive study treatment of RBS2418 or Placebo to Match plus Best Supportive Care with a treatment period consisting of 21-day cycles up to two years or until there is progressive disease (PD), death, withdrawal, or study completion, whichever comes first.
Adverse events (AEs) will be monitored throughout the study and graded in severity according to the guidelines outlined in the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. AEs will be collected until up to 30 days after the end of treatment or until resolution, whichever comes first. Serious Adverse Events (SAEs) will be collected for 90 days after the end of treatment, or if the subject initiates new anti-cancer therapy, then 30 days after the end of treatment, whichever is earlier.
- Being tested
- RBS2418, Placebo
- Keywords
- Advanced, Metastatic, Progressive Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBS2418Drug
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.
PlaceboDrug
Placebo to Match RBS2418
| Study group | Role | What they receive |
|---|---|---|
| Group A: EG+ [ENPP1 and cGAS(Cyclic GMP-AMP synthase) positive] RBS2418 plus Best Supportive Care | Active comparator | RBS2418: 200 mg (2 RBS2418 capsules), PO (by mouth), BID (twice a day) plus Best Supportive Care Receives: Drug: RBS2418 |
| Group B: EG+ (ENPP1 and cGAS positive) Placebo plus Best Supportive Care | Placebo comparator | Placebo: 2 placebo capsules, PO, BID plus Best Supportive Care Receives: Drug: Placebo |
| Group C: EG- (ENPP1 and/or cGAS negative) RBS2418 plus Best Supportive Care | Active comparator | RBS2418: 200 mg (2 RBS2418 capsules), PO, BID plus Best Supportive Care Receives: Drug: RBS2418 |
| Group D: EG- (ENPP1 and/or cGAS negative) Placebo plus Best Supportive Care | Placebo comparator | Placebo: 2 placebo capsules, PO, BID plus Best Supportive Care Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Time in months from randomization until the first radiographic documentation of objective progression, as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or death from any cause
Measured: From randomization until the first radiographic documentation of objective progression or death from any cause, assessed up to 2 years.
Overall Survival
Time in months from the date of randomization to the date of death from any cause
Measured: From randomization until death from any cause, assessed up to 2 years.
Secondary outcomes (2)
Duration of Response (DOR)
DOR is defined as the time in months from initial response [when complete response (CR) or partial response (PR) is first determined] to disease progression or death, whichever comes first.
Measured: From initial response to disease progression or death, assessed up to 2 years.
Disease Control Rate (DCR)
DCR is defined as the percentage of subjects who achieve a complete response (CR), a partial response (PR) or stable disease (SD).
Measured: From randomization to end of treatment or disease progression, assessed up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start17 Jan 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riboscience, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tam Anh Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824064
- Sponsor's protocol ID
- RBS2418-2001
- Acronym
- VISTA-1
- Status last verified
- Nov 2026
- First submitted
- 30 Jan 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of RBS2418 Plus Best Supportive Care (BSC) in Subjects With Advanced, Metastatic, and Progressive Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06824064
- Acronym / sponsor ID
- VISTA-1 / RBS2418-2001
- Keywords
- Advanced, Metastatic, Progressive Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Riboscience, LLC.Industry (pharma, biotech, devices)
- Collaborators
- Tam Anh Research Institute
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Feb 2025 (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.
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).
Detailed description
In this Phase 2a study, subjects must have failed, been unable to tolerate, or declined to take known standard-of-care (SOC) therapies. Subjects must have measurable disease per RECIST 1.1, an Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1 or 2, and predicted life expectancy of greater or equal to 3 months.
Up to approximately 150 subjects will be enrolled and will receive therapy as part of their respective treatment group. Subjects will receive study treatment of RBS2418 or Placebo to Match plus Best Supportive Care with a treatment period consisting of 21-day cycles up to two years or until there is progressive disease (PD), death, withdrawal, or study completion, whichever comes first.
Adverse events (AEs) will be monitored throughout the study and graded in severity according to the guidelines outlined in the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. AEs will be collected until up to 30 days after the end of treatment or until resolution, whichever comes first. Serious Adverse Events (SAEs) will be collected for 90 days after the end of treatment, or if the subject initiates new anti-cancer therapy, then 30 days after the end of treatment, whichever is earlier.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: EG+ [ENPP1 and cGAS(Cyclic GMP-AMP synthase) positive] RBS2418 plus Best Supportive Care | Active comparator | Drug: RBS2418RBS2418: 200 mg (2 RBS2418 capsules), PO (by mouth), BID (twice a day) plus Best Supportive Care |
| Group B: EG+ (ENPP1 and cGAS positive) Placebo plus Best Supportive Care | Placebo comparator | Drug: PlaceboPlacebo: 2 placebo capsules, PO, BID plus Best Supportive Care |
| Group C: EG- (ENPP1 and/or cGAS negative) RBS2418 plus Best Supportive Care | Active comparator | Drug: RBS2418RBS2418: 200 mg (2 RBS2418 capsules), PO, BID plus Best Supportive Care |
| Group D: EG- (ENPP1 and/or cGAS negative) Placebo plus Best Supportive Care | Placebo comparator | Drug: PlaceboPlacebo: 2 placebo capsules, PO, BID plus Best Supportive Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age on the day of signing informed consent.
- Male and female subjects with advanced, metastatic, progressive CRC who have received, been ineligible for, intolerant to, or declined all approved standard of care (SOC) therapies for metastatic CRC, as per local SOC treatment regimens. Additionally, subjects must have documented PD based on two scans performed within 2 to 4 months of study initiation.
- Have histologically or cytologically confirmed CRC diagnosis based on pathology report.
- Willing to submit a pre-treatment tissue sample (archival, or fresh tissue if archival is not available).
Key exclusion criteria (6 listed)
- Any approved anti-cancer therapy including chemotherapy, targeted small molecule therapy, systemic immunotherapy, or radiation therapy within 2 weeks prior to the first dose of study treatment; or if subject has not recovered (i.e., ≤ to Grade 1 or returned to baseline level) from AEs due to a previously administered agent; the following exceptions are allowed:
- Subjects with evidence of rapid progression on prior therapy resulting in rapid clinical deterioration.
- Malignancies other than indications open for enrollment within 3 years prior to Day 1, except for those with negligible risk of metastasis or death treated with expected curative outcome, undergoing active surveillance, or treatment-naïve for indolent tumors.
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 |
|---|---|---|
| RBS2418RBS2418 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. | Drug | Group A: EG+ [ENPP1 and cGAS(Cyclic GMP-AMP synthase) positive] RBS2418 plus Best Supportive Care, Group C: EG- (ENPP1 and/or cGAS negative) RBS2418 plus Best Supportive Care |
| PlaceboPlacebo to Match RBS2418 | Drug | Group B: EG+ (ENPP1 and cGAS positive) Placebo plus Best Supportive Care, Group D: EG- (ENPP1 and/or cGAS negative) Placebo plus Best Supportive Care |
Primary outcome
Progression Free Survival
Time frame: From randomization until the first radiographic documentation of objective progression or death from any cause, assessed up to 2 years.
Time in months from randomization until the first radiographic documentation of objective progression, as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or death from any cause
Overall Survival
Time frame: From randomization until death from any cause, assessed up to 2 years.
Time in months from the date of randomization to the date of death from any cause
2 secondary outcomes
Duration of Response (DOR)
Time frame: From initial response to disease progression or death, assessed up to 2 years.
Disease Control Rate (DCR)
Time frame: From randomization to end of treatment or disease progression, assessed up to 2 years.
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 5 Nov 2026.
- Individual participant dataSharing planned: No
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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.
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RBS2418 in people with Metastatic Colorectal Cancer and Advanced Colorectal Cancer, run by Riboscience, LLC. at 8 sites in 3 countries.
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 4 inclusion and 6 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Vietnam, Puerto Rico. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Riboscience Clinical Trials ((415) 754-3182, clinicaltrials@riboscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: From randomization until the first radiographic documentation of objective progression or death from any cause, assessed up to 2 years.). The study lists 2 primary outcomes in all. 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 5 Nov 2026.