← Back to Search

Monoclonal Antibodies

Ivermectin + Balstilimab for Breast Cancer

Phase 1 & 2
Recruiting
Led By Yuan Yuan, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 2 from prior anti-cancer therapy
Patients must have progressed on 1-2 prior lines of systemic therapy (chemotherapy and/or drug-antibody conjugate) in the metastatic setting
Must not have
Known history of active TB (Mycobacterium tuberculosis)
History of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of study treatment to death or last contact. assessed up to 6 years
Awards & highlights

Summary

This trial uses ivermectin and balstilimab to treat metastatic triple negative breast cancer. Ivermectin might stop new cancer growths, and balstilimab helps the immune system attack cancer cells. The goal is to shrink tumors and improve patient outcomes.

Who is the study for?
This trial is for adults with metastatic triple negative breast cancer who have tried 1-2 systemic therapies. They must be in good health otherwise, with a life expectancy of over 3 months and an ECOG score of ≤1. Women must not be pregnant or breastfeeding and agree to contraception. People can't join if they've had certain heart problems, severe lung conditions, active infections like Hepatitis B/C or HIV, autoimmune diseases requiring recent treatment, brain metastases unless stable without steroids for 14 days, or are on other clinical trials.
What is being tested?
The trial is testing the combination of Ivermectin and Balstilimab to see how well it works in shrinking tumors in patients with advanced breast cancer. It's a phase II study which means they're looking at effectiveness and determining the best dose while monitoring side effects closely.
What are the potential side effects?
Possible side effects include reactions related to the immune system since Balstilimab is an immunotherapy drug that may cause inflammation in various organs. Ivermectin could also lead to skin rashes or liver issues as it interferes with tumor cell growth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have recovered from side effects of cancer treatment, except for hair loss.
Select...
My cancer has worsened after 1-2 treatments in the metastatic stage.
Select...
I am 18 years old or older.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
I am a woman who can have children and my pregnancy test is negative.
Select...
I am 18 years old or older.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
My breast cancer is triple negative, confirmed by tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an active tuberculosis infection.
Select...
I have had pneumonitis treated with steroids or currently have it.
Select...
I do not have serious heart problems like recent heart attacks or severe heart failure.
Select...
I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
Select...
I have received an organ or tissue transplant from another person.
Select...
I am currently being treated for an infection.
Select...
I have been diagnosed with HIV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of study treatment to death or last contact. assessed up to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of study treatment to death or last contact. assessed up to 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events
Objective response rate
Secondary study objectives
Clinical benefit rate
Duration of response
Overall survival
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (ivermectin, balstilimab)Experimental Treatment2 Interventions
Patients receive ivermectin PO QD on days 1-3, 8-10, and 15-17. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also receive balstilimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ivermectin
FDA approved

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,496 Total Patients Enrolled
43 Trials studying Breast Cancer
6,649 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,959 Total Patients Enrolled
945 Trials studying Breast Cancer
1,543,964 Patients Enrolled for Breast Cancer
Yuan YuanLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Breast Cancer
20 Patients Enrolled for Breast Cancer

Media Library

Balstilimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05318469 — Phase 1 & 2
Breast Cancer Research Study Groups: Treatment (ivermectin, balstilimab)
Breast Cancer Clinical Trial 2023: Balstilimab Highlights & Side Effects. Trial Name: NCT05318469 — Phase 1 & 2
Balstilimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05318469 — Phase 1 & 2
~27 spots leftby Oct 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top