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Monoclonal Antibodies

Sacituzumab Tirumotecan for Gastroesophageal Cancer (TroFuse-015 Trial)

Phase 3
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants are eligible regardless of human epidermal growth factor receptor-2 (HER2) status. Participants who are HER2+ must have previously received trastuzumab
Has adequate organ function
Must not have
Has received prior radiotherapy within 2 weeks before the first dose of study intervention, has radiation-related toxicities, requiring corticosteroids, and/or has had radiation pneumonitis
Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~ 48 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will compare how safe and effective a drug called sacituzumab tirumotecan is compared to the usual treatment in patients with advanced stomach or esophageal cancer. The main goal

Who is the study for?
This trial is for adults with advanced or metastatic gastroesophageal adenocarcinoma who have tried at least two prior treatments. They must be able to perform daily activities with little to no assistance (ECOG status 0-1), swallow pills, and have tumors that can be measured by scans. Their organs should function well, and they need a specific protein on their cancer cells (TROP2) which will be tested.
What is being tested?
The study tests Sacituzumab Tirumotecan against doctors' choice of standard treatments like Docetaxel, Irinotecan, Paclitaxel, or Trifluridine-Tipiracil in patients with gastroesophageal cancer. The main goal is to see if Sacituzumab Tirumotecan helps patients live longer compared to the other drugs.
What are the potential side effects?
Sacituzumab Tirumotecan may cause side effects such as nausea, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems, fatigue, hair loss and allergic reactions. Side effects vary based on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer's HER2 status does not exclude me, but if HER2+, I've had trastuzumab.
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My organs are functioning well.
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My cancer has worsened after at least 2 treatments.
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My cancer is a type that started in the stomach or esophagus and cannot be surgically removed.
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My cancer can be measured by scans according to RECIST 1.1.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had radiotherapy less than 2 weeks ago or have side effects from it needing steroids.
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I have a severe eye condition that affects my cornea or eyelids.
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I have lost more than 20% of my weight in the last 3 months.
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I have an active inflammatory bowel condition or a history of one.
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I have not had major surgery or significant injury in the last 4 weeks.
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I experience significant numbness or pain in my hands or feet.
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I do not have serious heart or stroke-related conditions.
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I have active hepatitis B or C, or a history of these infections.
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I am taking medication that affects liver enzymes and can't stop it for the study.
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I have another cancer that is getting worse or was treated in the last 3 years.
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I have active brain metastases or cancer in the lining of my brain.
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I am currently being treated for an infection with medication.
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I have been treated with specific cancer drugs targeting TROP2 or topoisomerase 1.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~ 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~ 48 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
Overall Survival (OS)
Secondary study objectives
Duration of Response (DOR)
Number of Participants Who Discontinue Study Intervention Due to an AE
Number of Participants Who Experience an Adverse Event (AE)
+2 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sacituzumab tirumotecanExperimental Treatment3 Interventions
Participants will receive sacituzumab tirumotecan at a dose of 4mg/kg by intravenous (IV) infusion on days 1, 15, and 29 of every 42-day cycle.
Group II: Treatment of Physician's Choice (TPC)Active Control5 Interventions
TPC include either trifluridine-tipiracil (35 mg/m\^2 orally (PO) twice a day (BID) on days 1 to 5 and 8 to 12 of every 28-day cycle), irinotecan (150 mg/m\^2 IV on days 1 and 15 of every 28-day cycle), paclitaxel (80 mg/m\^2 IV on days 1, 8, and 15 of every 28-day cycle), or docetaxel (75 mg/m\^2 IV on day 1 of every 21-day cycle).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rescue medication
2012
Completed Phase 3
~3860

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,985 Previous Clinical Trials
5,178,251 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,868 Previous Clinical Trials
8,082,180 Total Patients Enrolled
~300 spots leftby Jan 2027
Unbiased ResultsWe believe in providing patients with all the options.
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