NCT05243862

Safety and Activity of PolyPEPI1018 Plus Atezolizumab in Colorectal Cancer.

Phase II Study of PolyPEPI1018 Vaccine in Combination with Atezolizumab in Participants with Relapsed or Refractory Microsatellite-stable Metastatic Colorectal Cancer.

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Treos Bio Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open label, phase II trial to determine the safety, tolerability, and immunogenicity and initial clinical activity of the combination treatment of PolyPEPI1018 vaccine and atezolizumab in participants with MSS CRC who have progressed on 2 or 3 prior regimens.

Detailed description

This is a multicenter, open label, phase II trial to determine the safety, tolerability, and immunogenicity and initial clinical activity of the combination treatment of PolyPEPI1018 vaccine and atezolizumab in participants with MSS CRC who have progressed on 2 or 3 prior regimens. Both agents will be administered on an every-3-week schedule until documented progression. A Simon's 2-stage design will be used for the initial assessment of efficacy.

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
DRUG	PolyPEPI1018	PolyPEPI1018 vaccine contains 6 synthetic peptides emulsified with the adjuvant Montanide™. The peptides were selected to induce T cell responses against 12 dominant epitopes from 7 tumor-specific antigens, which are the most frequently expressed antigens in colorectal cancer.
DRUG	Atezolizumab	Atezolizumab is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1.

Timeline

• Start date: 2022-06-02
• Primary completion: 2024-07-08
• Completion: 2026-06-02
• First posted: 2022-02-17
• Last updated: 2025-03-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study