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Monoclonal Antibodies

Sacituzumab Govitecan + Capecitabine for Gastrointestinal Cancer

Phase 1

Recruiting

Research Sponsored by Henry Ford Health System

Eligibility Criteria Checklist

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

Must have

Male subjects who are partners of women of childbearing potential must use a condom and spermicide

Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, ANC ≥ 1500/mm3, and platelets ≥ 100,000/μL)

Must not have

Requirement for ongoing therapy with or prior use of any prohibited medications listed in protocol

Previous receipt of topoisomerase 1 inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination of drugs, sacituzumab govitecan and capecitabine, for patients with advanced gastrointestinal cancers that have not responded to standard treatments. Researchers

Who is the study for?

This trial is for adults with advanced gastrointestinal cancers, including gastroesophageal, colorectal, and pancreaticobiliary types that haven't responded to standard treatments. Participants must have proper liver and kidney function, adequate blood counts without support, and agree to use effective contraception methods.

What is being tested?

The study tests the combination of Sacituzumab Govitecan (an antibody-drug conjugate) with Capecitabine (a chemotherapy drug) in patients whose gastrointestinal cancer has progressed after standard therapy. It also looks at how a biomarker called Trop-2 correlates with outcomes.

What are the potential side effects?

Potential side effects may include typical chemotherapy-related issues like nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems. There might also be specific reactions related to Sacituzumab Govitecan.

Eligibility Criteria

Inclusion Criteria

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

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I am a man and will use a condom and spermicide if my partner can have children.

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My blood counts are within the required range without needing transfusions or growth support.

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My cancer originates from the gastrointestinal tract and standard treatments have not worked.

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My liver is functioning well according to recent tests.

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My kidneys are working well enough (Creatinine clearance ≥ 30 mL/min).

Exclusion Criteria

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

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I am not taking any medications that the study does not allow.

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I have previously been treated with topoisomerase 1 inhibitors.

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I have ongoing inflammatory bowel disease or had a GI perforation.

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I do not have recent heart attacks, serious heart rhythm problems, or weak heart pumping function.

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I am currently taking antibiotics for a serious infection.

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I have a history of HIV or active hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 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

Primary Endpoint

Secondary study objectives

Adverse Events (AEs)

Duration of Response (DoR)

Objective response rate (ORR)

+2 more

Other study objectives

Exploratory Endpoint

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: Sacituzumab govitecan and capecitabineExperimental Treatment2 Interventions

The trial has three dose levels. Dose level -1 has capecitabine at 500mg/m2 twice daily taken orally for two weeks on and one week off, plus sacituzumab govitecan at 7.5mg/kg given intravenously on Days 1 and 8. Each cycle is 21 days. Dose level 0 has capecitabine at 500mg/m2 and sacituzumab govitecan at 10mg/kg. Dose level 1 has capecitabine at 825mg/m2 and sacituzumab govitecan at 10mg/kg.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Capecitabine

2013

Completed Phase 3

~4280

0 / 11Eligibility criteria met