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Monoclonal Antibodies

Sacituzumab Govitecan for Bile Duct Cancer

Phase 2

Recruiting

Led By Anup K Kasi Loknath Kumar

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2

Locally advanced, recurrent or metastatic cholangiocarcinoma) after progressing or intolerant to at least one line of systemic therapy

Must not have

Known homozygosity in the UGT1A1*28 allele associated with irinotecan toxicity

Met any of the following criteria for cardiac disease: Myocardial infarction or unstable angina pectoris within 6 months of enrollment. History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation. New York Heart Association (NYHA) class III or greater congestive heart failure or left ventricular ejection fraction of < 40%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment, up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a treatment called sacituzumab govitecan for patients with a type of cancer called cholangiocarcinoma. This cancer can be locally advanced, recurrent, or

Who is the study for?

This trial is for patients with advanced forms of bile duct cancer, including those whose cancer has spread locally, returned after treatment, or metastasized. Participants must have measurable disease and be able to undergo procedures like biopsies and scans.

What is being tested?

The trial is testing Sacituzumab Govitecan's effectiveness on cholangiocarcinoma. It involves a monoclonal antibody targeting TROP2 receptors on tumor cells to deliver the toxic agent SN-38 directly to them.

What are the potential side effects?

Sacituzumab Govitecan may cause side effects such as nausea, diarrhea, hair loss, fatigue, decreased blood cell counts leading to higher infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and am up and about more than half of the day.

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My bile duct cancer has worsened or didn't respond to at least one treatment.

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My kidneys are functioning well enough for treatment.

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I am 18 years old or older.

Exclusion Criteria

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

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I have a genetic variation linked to higher risk of side effects from irinotecan.

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I have had serious heart issues or heart failure recently.

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I have been treated with topoisomerase 1 inhibitors before.

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I am on medication for an active infection but not just for prevention.

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I have HIV with a detectable viral load.

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I haven't had chemotherapy, biologics, or trial drugs within 4 weeks or 5 half-lives before starting the study drug.

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I have not received any live vaccines in the last 30 days.

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I am not using, nor plan to use other cancer treatments during this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment, up to 2 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

Overall response rate

Secondary study objectives

Anti-tumor activity: Disease control rate

Anti-tumor activity: Duration of response

Incidence of adverse events

+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: Treatment (Sacituzumab govitecan)Experimental Treatment6 Interventions

Patients receive sacituzumab govitecan IV over 1-3 hours on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, PET/CT or MRI scans, and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Computed Tomography

2017

Completed Phase 2

~2790