Safety and Activity of PolyPEPI1018 Plus Atezolizumab in Colorectal Cancer.

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Treos Bio Limited
Study ID
NCT05243862
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

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

Interventions

  • PolyPEPI1018 — DRUG
    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.
  • Atezolizumab — DRUG
    Atezolizumab is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1.

Study Details

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.

Key Dates

Start date
Jun 2, 2022
Status verified
Nov 2024
Primary completion
Jul 8, 2024
Completion
Jun 2, 2026

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PolyPEPI1018 plus Atezolizumab
    Participants receive every 3 weeks PolyPEPI1018 CRC Vaccine (Emulsified solution, 0.2 mg/peptide, 6 peptides total, and Montanide™ ISA51VG adjuvant), by SC injection in combination with Atezolizumab (Injectable solution,1200mg/20mL) by IV injection.

Primary Outcome Measure

The incidence and severity treatment related Adverse Events [ Time Frame: From 1st dose until 90-Days after last dose ]

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo ClinicPhoenixArizona85054-
Mayo ClinicJacksonvilleFlorida32224-
Mayo ClinicRochesterMinnesota55905-

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