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

Part of paid clinical trials in Newark, Delaware.

Sponsor
Riboscience, LLC.
Study ID
NCT06824064
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Colorectal Cancer
  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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).

Key Dates

Start date
Jan 17, 2025
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group A: EG+ [ENPP1 and cGAS(Cyclic GMP-AMP synthase) positive] RBS2418 plus Best Supportive Care
    RBS2418: 200 mg (2 RBS2418 capsules), PO (by mouth), BID (twice a day) plus Best Supportive Care
  • Placebo Comparator: Group B: EG+ (ENPP1 and cGAS positive) Placebo plus Best Supportive Care
    Placebo: 2 placebo capsules, PO, BID plus Best Supportive Care
  • Active Comparator: Group C: EG- (ENPP1 and/or cGAS negative) RBS2418 plus Best Supportive Care
    RBS2418: 200 mg (2 RBS2418 capsules), PO, BID plus Best Supportive Care
  • Placebo Comparator: Group D: EG- (ENPP1 and/or cGAS negative) Placebo plus Best Supportive Care
    Placebo: 2 placebo capsules, PO, BID plus Best Supportive Care

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. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Christiana CareNewarkDelaware19718-
Community Clinical TrialsKingwoodTexas77339-

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