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Checkpoint Inhibitor

Bria-IMT + CPI for Advanced Breast Cancer (BRIA-ABC Trial)

Phase 3

Recruiting

Research Sponsored by BriaCell Therapeutics Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be ≥ 18 years of age

Have histological confirmation of breast cancer with either locally recurrent unresectable and/or metastatic lesions, and have failed prior therapy

Must not have

Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline

Serum creatinine OR Measured OR calculated Creatinine Clearance (CrCl) (GFR can also be used in place of creatinine or CrCl) >2.0 × ULN or <30 mL/min for participants with creatinine levels >2.0 × institutional ULN

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 months

Awards & highlights

Summary

This trial evaluates a new treatment for advanced breast cancer with no other alternatives available.

Who is the study for?

This trial is for adults over 18 with advanced metastatic or locally recurrent breast cancer who have no other treatment options. Eligible patients must have failed prior therapy, not be suitable for local treatments, and meet specific criteria if they have brain metastases. They cannot join if they've had recent chemotherapy, radiotherapy, surgery, certain abnormal lab values, a history of other malignancies or immune conditions, unresolved toxicity from previous therapies, or are pregnant.

What is being tested?

The study compares the Bria-IMT regimen combined with retifanlimab (a checkpoint inhibitor) to treatments chosen by physicians in patients with late-stage breast cancer. It's an open-label trial where participants know which treatment they're receiving and aims to see which method improves overall survival when standard therapies aren't available.

What are the potential side effects?

Potential side effects may include reactions related to the immune system such as inflammation in various organs due to retifanlimab; cyclophosphamide might cause nausea, hair loss and lower blood cell counts; interferon can lead to flu-like symptoms; plus risks associated with physician-chosen treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My breast cancer is advanced and previous treatments didn't work.

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My breast cancer has spread to my brain.

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My cancer cannot be treated with surgery or radiation alone.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My side effects from previous treatments have mostly gone away.

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My kidney function is within the required range.

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I am not taking any medications that are not allowed in the study.

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I have a history of cancer, HIV, immune problems, autoimmune disease, or ongoing infections.

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I have not had radiotherapy in the last 14 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival

Secondary study objectives

CNS Event free survival (EFS)

Clinical Benefit Rate (CBR)

Overall response rate (ORR)

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Bria-IMT Regimen AloneExperimental Treatment3 Interventions

The Bria-IMT regimen: Day -2 or -3 Cyclophosphamide 300mg/m2 Day 0 SV-BR-1-GM given intradermally divided into 4 inoculations Day 1-3 CPI infusion plus interferon administered intra-dermally within each SV-BR-1-GM inoculation site

Group II: Bria-IMT Regimen + CPIExperimental Treatment4 Interventions

Group III: Treatment of Physician's ChoiceActive Control1 Intervention

TPC consists of eribulin, carboplatin, capecitabine, gemcitabine, vinorelbine or taxanes in accordance with the investigators' and institutional standard of care. The specific details of the selected regimen must include every detail of administration including frequency, sequencing (for multi-agent regimens), duration of infusion or oral administration, planned dose, dose prescribed, dose administered, dose adjustments after initial prescription or start of TPC treatment, and any other change in TPC from its initial election prior to randomization.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Retifanlimab

2018

Completed Phase 2

~320

Cyclophosphamide

2010

Completed Phase 4

~2320

SV-BR-1-GM

2017

Completed Phase 2

~30

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

BriaCell Therapeutics CorporationLead Sponsor

3 Previous Clinical Trials

78 Total Patients Enrolled

2 Trials studying Breast Cancer

54 Patients Enrolled for Breast Cancer

Giuseppe Del Priore, MD MPHStudy DirectorBriaCell Therapeutics

~190 spots leftby Jun 2025

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