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Monoclonal Antibodies

Sacituzumab Govitecan + Zimberelimab + Radiation for Breast Cancer with Brain Metastases

Phase 1 & 2

Recruiting

Led By Kamran Ahmed, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Age ≥ 18

Triple negative breast cancer with ≤ 5% expression of estrogen receptor (ER) and progesterone receptor (PR)

Must not have

Presence of leptomeningeal disease

Known history of HIV-1 or 2 with detectable viral load

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 33 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of combining two drugs, Sacituzumab Govitecan and Zimberelimab, with stereotactic radiation in people with a specific type of

Who is the study for?

This trial is for individuals with metastatic triple-negative breast cancer that has spread to the brain. Participants should not have had prior treatment with Sacituzumab Govitecan or immune checkpoint inhibitors, and must be suitable for stereotactic radiation.

What is being tested?

The study is testing the combination of a drug called Zimberelimab and another drug, Sacituzumab Govitecan, along with focused radiation therapy (SRS), against using just Sacituzumab Govitecan. It aims to see if adding Zimberelimab and SRS improves outcomes.

What are the potential side effects?

Potential side effects include reactions at the injection site, nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, liver issues, and possible effects from radiation like headaches or hair loss.

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 triple negative with very low ER and PR levels.

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I have a brain tumor that can be measured and is at least 0.5 cm big.

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I can take care of myself and am up and about more than half of my waking hours.

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I have been treated with taxane and anthracycline chemotherapy before.

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I have 15 or fewer brain tumors eligible for targeted radiation.

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My largest brain tumor is 4 cm or smaller.

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My breast cancer has spread to my brain, confirmed by MRI or surgery.

Exclusion Criteria

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

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My cancer has spread to the lining of my brain and spinal cord.

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I have HIV with a detectable viral load.

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I have an autoimmune disease, but it's not one of the exceptions listed.

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I have or had lung inflammation that needed steroids.

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I do not have serious heart issues or need extra oxygen.

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I am currently taking antibiotics for a serious infection.

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I have recently received treatment with drugs targeting cancer.

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I have been treated with topoisomerase 1 inhibitors for brain metastases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 33 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 33 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 33 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

Phase I: Neurologic Toxicity

Phase II: Progression Free Survival (PFS)

Secondary study objectives

Phase II: Distant Brain Control

Phase II: Extracranial Progression Free Survival (PFS)

Phase II: Intracranial Progression Free Survival (PFS)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SG + Zimberelimab with SRSExperimental Treatment3 Interventions

Treatment will be initiated with SRS followed 1 week later by SG on days 1 and 8 (10mg/kg) with zimberelimab on day 1 (360 mg IV) repeated every 3 weeks follow-up imaging response assessments will be conducted at q9 week intervals.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zimberelimab

2020

Completed Phase 2

~230

Stereotactic Radiation

2014

Completed Phase 2

~170