Combination Therapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

+13 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: BriaCell Therapeutics Corporation

No Placebo Group

Trial Summary

What is the purpose of this trial?This is an open-label, phase I/II double arm study of the SV-BR-1-GM regimen in combination with retifanlimab in patients with metastatic or locally recurrent breast cancer who have failed standard therapy. Patients will receive the SV-BR-1-GM regimen with combination immunotherapy. There will be an initial evaluation of the combination of the SV-BR-1-GM regimen with retifanlimab every 3 weeks. If this is found to be safe and well tolerated in a cohort of at least 12 patients (dose-limiting toxicities (DLTs) in less than 30% of the patients evaluated), then an expansion cohort of up to 24 patients will be treated with that combination. These will be randomized to two regimens differing in the timing of checkpoint inhibitor administration.

Eligibility Criteria

This trial is for women over 18 with Stage IV triple-negative breast cancer that can't be treated locally and who have survived past standard therapies. They must expect to live at least 4 more months, not have severe psychiatric issues or major medical conditions, no recent immunosuppressive treatments, vaccines, transplants, or autoimmune disease treatments.

Inclusion Criteria

My cancer is not HER2 positive.

My cancer is in Stage IV.

My recurring cancer cannot be treated with surgery or radiation.

+3 more

Exclusion Criteria

I have been treated for an autoimmune disease in the last 2 years.

I have a history of colitis.

I have severe psychiatric or major medical issues.

+8 more

Participant Groups

The study tests the SV-BR-1-GM regimen combined with retifanlimab on patients with advanced breast cancer. Initially tested on a small group for safety and tolerability; if successful, expanded to more patients randomized into two groups based on treatment timing.

2Treatment groups

Experimental Treatment

Group I: SV-BR-1-GM, retifanlimab combination original sequenceExperimental Treatment4 Interventions

Subjects will be treated with the SV-BR-1-GM regimen in combination with retifanlimab with cycles every 3 weeks

Group II: SV-BR-1-GM, retifanlimab combination alternative sequenceExperimental Treatment4 Interventions

Subjects will be treated with the SV-BR-1-GM regimen in combination with retifanlimab as follows: Cycle 1: SV-BR-1-GM only Cycle 2: resume retifanlimab on Day 2±1 Cycle 3 and beyond: retifanlimab can be administered on Day -2, Day 0, 1, 2, or 3.

Retifanlimab is already approved in United States for the following indications:

🇺🇸 Approved in United States as Zynyz for: