Phase 1b Study to Evaluate ATP128, VSV-GP128 and BI 754091, in Patients With Stage IV Colorectal Cancer
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
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 and of heterologous prime-boost ATP128 +
VSV-GP128 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 (Ezabenlimab) compound which belongs to the human immunoglobulin G4
(IgG4) subclass of antibodies.
VSV-GP is a recombinant chimeric vesicular stomatitis virus (VSV, Indiana strain
Rhabdoviridae) which carries the envelope glycoprotein (GP) of the visceral non neurotropic
WE-HPI strain of the Lymphocytic choriomeningitis virus (LCMV, Arenaviridae) instead of the
native VSV glycoprotein (G) and is developed as integral part of the prime-boost regimen
together with ATP128.
The Sponsor plans to enrol 96 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, 2c: 30 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 (4-6 months duration at minimum)
- Cohorts 2b, 4b: 30 patients with stage IV MSS/MMRp liver-limited disease
Patients eligible for this study will be enrolled in one of the 8 cohorts depending on their
disease:
- Patients in Cohort 1a will receive ATP128 as single agent
- Patients in Cohorts 1b, 2a, 2b, 2c will receive ATP128 in combination with BI 754091
- Patients in Cohorts 3, 4a, 4b will receive ATP128 and VSV-GP128 in combination with BI
754091