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Evaluation of RBS2418 in Patients With Advanced, Metastatic, and Progressive Colorectal Cancer

ConditionsMetastatic Colorectal CancerAdvanced Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRiboscience, LLC.

About 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 does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • RBS2418

    Drug

    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.

  • Placebo

    Drug

    Placebo to Match RBS2418

Treatment groups

150 Participants
are divided into 4 treatment groups
Group A: Group A: EG+ [ENPP1 and cGAS(Cyclic GMP-AMP synthase) positive] RBS2418 plus Best Supportive CareActive comparator 1 intervention
Group B: Group B: EG+ (ENPP1 and cGAS positive) Placebo plus Best Supportive CarePlacebo comparator 1 intervention
Group C: Group C: EG- (ENPP1 and/or cGAS negative) RBS2418 plus Best Supportive CareActive comparator 1 intervention
Group D: Group D: EG- (ENPP1 and/or cGAS negative) Placebo plus Best Supportive CarePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From randomization until the first radiographic documentation of objective progression or death from any cause, assessed up to 2 years.
2

Overall Survival

Time in months from the date of randomization to the date of death from any cause

Time frame
From randomization until death from any cause, assessed up to 2 years.

Secondary outcomes

1

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.

Time frame
From initial response to disease progression or death, assessed up to 2 years.
2

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).

Time frame
From randomization to end of treatment or disease progression, assessed up to 2 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Riboscience, LLC.

Lead sponsor

Tam Anh Research Institute

Collaborator

Source ClinicalTrials.gov
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