Last updated on November 2019

Phase 1b Study to Evaluate ATP128 With or Without BI 754091 in Patients With Stage IV Colorectal Cancer

Brief description of study

This is a multi-center, non-randomised Phase 1b study to evaluate the safety and tolerability of ATP128 alone or in combination with BI 754091.

ATP128 is a self-adjuvanted chimeric recombinant protein vaccine being developed in combination with programmed cell death 1 (PD-1) blockade for the treatment of microsatellite stable (MSS) patients not responding to PD-1 blockade. The PD-1 inhibitor being tested with ATP128 is the BI 754091 compound which belongs to the human immunoglobulin G4 (IgG4) subclass of antibodies.

The Sponsor plans to enrol 32 patients with histologically or cytologically confirmed stage IV colorectal cancer coming form three different patient populations:

  • Cohort 1a: 6 patients with stage IV colorectal cancer (CRC) having failed standard of care (SoC) therapies
  • Cohorts 1b, 2a: 11 patients with stage IV microsatellite stable/mismatch repair-proficient (MSS/MMRp) CRC being in stable disease (SD) or partial response (PR) after first line of SoC (6 months duration at minimum)
  • Cohort 2b: 15 patients with stage IV MSS/MMRp hepatic-limited metastatic CRC

Patients eligible for this study will be enrolled in one of the 4 cohorts depending on their

  • Patients in Cohort 1a will receive ATP128 as single agent
  • Patients in Cohorts 1b, 2a will receive ATP128 in combination with BI 754091
  • Patients in Cohorts 2b will receive ATP128 in combination with BI 754091 before and after the liver surgery

Clinical Study Identifier: NCT04046445

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Honor Health Institute

Scottsdale, AZ United States
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