PolyPEPI1018 + Atezolizumab for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byJoleen M Hubbard

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Treos Bio Limited

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults over 18 with metastatic colorectal cancer (MSS CRC) who have tried and progressed on 2-3 prior treatments can join this trial. They must be in good physical condition, not pregnant or breastfeeding, willing to undergo biopsies and provide consent. Excluded are those with autoimmune diseases, recent vaccines or surgeries, active infections like HIV/HBV/HCV, CNS metastases, history of severe allergies to vaccines or proteins.

Inclusion Criteria

I am fully active or can carry out light work.

I am not pregnant, not breastfeeding, and meet one of the required conditions.

I agree to have a biopsy before and 6 weeks after starting the study therapy, or I have tissue samples available from the last 3 months.

+21 more

Exclusion Criteria

My liver condition is severe.

You have a history of an autoimmune disease.

Pregnant or breast-feeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 90 days after the last dose of study treatment

+18 more

Participant Groups

The trial is testing the combination of a new vaccine called PolyPEPI1018 with an existing cancer drug Atezolizumab in patients whose colorectal cancer has worsened after previous treatments. It's an open-label phase II study focusing on safety and how well the body responds to this combo.

1Treatment groups

Experimental Treatment

Group I: PolyPEPI1018 plus AtezolizumabExperimental Treatment2 Interventions

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.

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tecentriq for: