Evaluation of RBS2418 in Subjects With Advanced, Metastatic Solid Tumors

Conditions

• Advanced Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• RBS2418 — DRUG
  RBS2418 is a potent and selective small molecule inhibitor of ectonucleotide pyrophosphatase/phosphodiesterase I (ENPP1). RBS2418 as monotherapy potentially can have an activating effect on the anti-tumor innate immune response and lead to anti-tumor responses in adult subjects with advanced or metastatic tumors.
• Pembrolizumab — DRUG
  200 mg intravenously every 3 weeks
• Other approved anti-cancer therapy — DRUG
  Standard of care (SOC) therapy

Study Details

RBS2418 (investigational product) is a specific immune modulator, working through ectonucleotide pyrophosphatase/phosphodiesterase I (ENPP1), designed to lead to anti-tumor immunity by increasing endogenous 2'-3'-cyclic guanosine monophosphate-adenosine monophosphate (cGAMP) and adenosine triphosphate (ATP levels) and reducing adenosine production in the tumors. RBS2418 has the potential to be an important therapeutic option for subjects both as monotherapy and in combination with other cancer treatments including monotherapy and in combination with other cancer treatments including immunotherapy or chemotherapy. This study is an open-label, multi-site Phase 1a/1b study of RBS2418, a selective ENPP1 inhibitor, in combination with pembrolizumab or other approved anticancer therapies or as a monotherapy in subjects with advanced unresectable, recurrent or metastatic tumors. The phase 1a (dose escalation phase) has been completed. The Phase 1b expansion phase of the study has been increased in size and scope.

Key Dates

Start date

Jul 11, 2022

Status verified

Dec 2025

Primary completion

Apr 30, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

164 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Group A-1 (Completed)
  For Treatment Group A-1, a cohort of three (3) subjects will be dosed at the starting dose of 100 mg twice a day (BID) of RBS2418. Subsequent subjects will then be enrolled in serial, three (3) subject cohorts, with 100% dose increments (doubling the dose) until 800 mg BID
• Experimental: Treatment Group A-2 (Completed)
  For Treatment Group A-2, a cohort of three (3) subjects will be dosed at the starting dose of 100 mg twice a day (BID) of RBS2418 in combination with pembrolizumab 200 mg IV (administered on Day 1 and every 3 weeks). Subsequent subjects will then be enrolled in serial, three (3) subject cohorts, with 100% dose increments (doubling the dose) until 800 mg BID
• Experimental: Treatment Group B
  RBS2418 as Monotherapy or in combination with investigator-selected approved anticancer therapy at selected dose levels. (n\~140)

Primary Outcome Measure

Treatment emergent dose limiting toxicities (DLT) [ Time Frame: From 1- 21 days of the first cycle (each cycle is 21 days) ]

Central Contacts

• Riboscience Clinical Trials
  ‪(415) 754-3182‬
  [email protected]

Locations (14)

Find similar trials in Scottsdale, AZ

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