60 Participants NeededMy employer runs this trial

Ifinatamab Deruxtecan for Esophageal Cancer

Recruiting at 31 trial locations
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Overseen ByToll Free Number
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Merck Sharp & Dohme LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a new treatment, ifinatamab deruxtecan (I-DXd), can help individuals with esophageal squamous cell carcinoma (ESCC), a type of esophageal cancer. I-DXd targets cancer cells, delivering treatment directly to them to shrink or eliminate the cancer. The trial seeks participants whose ESCC has worsened despite one or two prior treatments. Eligible participants should have a type of ESCC that cannot be surgically removed and should not have other major health issues that could interfere with the trial. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to be among the first to benefit from this innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have an active infection requiring systemic therapy, it might not be allowed. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that ifinatamab deruxtecan is likely to be safe for humans?

Research has shown that ifinatamab deruxtecan (I-DXd) is generally safe to use, with side effects typically being mild and manageable with proper care. In earlier studies, some patients responded well to I-DXd, with the treatment helping to shrink tumors in those who had already undergone multiple treatments. Although side effects occurred, they were considered manageable. This suggests that the treatment is relatively safe, though individual experiences may vary.12345

Why do researchers think this study treatment might be promising for esophageal cancer?

Most treatments for esophageal cancer, like chemotherapy and radiation, work by attacking rapidly dividing cancer cells, but they can also harm healthy cells. Ifinatamab Deruxtecan (I-DXd) is unique because it targets cancer cells more precisely, using an antibody-drug conjugate that binds to specific proteins on the cancer cells before delivering a potent chemotherapy agent directly to them. This targeted approach minimizes damage to healthy cells and may lead to fewer side effects. Researchers are excited about I-DXd because its targeted mechanism shows promise for more effective treatment outcomes with potentially improved safety.

What evidence suggests that ifinatamab deruxtecan might be an effective treatment for esophageal cancer?

Research has shown that ifinatamab deruxtecan (I-DXd), a targeted cancer treatment, may help treat esophageal squamous cell carcinoma (ESCC). In earlier studies with a similar cancer, over half of the patients experienced tumor shrinkage, with a 54.8% response rate. This treatment targets a specific protein on cancer cells and delivers a drug to destroy them. Participants in this trial will receive I-DXd every three weeks until they meet criteria for progressive disease or discontinuation. These findings suggest that I-DXd could shrink or eliminate ESCC in some patients.23678

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic esophageal squamous cell carcinoma whose cancer has worsened after 1 or 2 previous treatments. Participants must have measurable disease, good organ function, and well-controlled HIV if infected.

Inclusion Criteria

I have HIV that is well-controlled with medication.
My esophageal cancer got worse after 1 or 2 treatments for advanced disease.
I have advanced or metastatic esophageal squamous cell carcinoma that can't be removed by surgery.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will be administered I-DXd every 3 weeks until progressive disease or discontinuation criteria are met

Up to approximately 18 months
Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 8 months

What Are the Treatments Tested in This Trial?

Interventions

  • Ifinatamab Deruxtecan (I-DXd)

Trial Overview

The study tests ifinatamab deruxtecan (I-DXd), a targeted antibody-drug conjugate that delivers chemotherapy directly to cancer cells. The main goal is to see how many patients' cancers shrink or disappear after treatment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: I-DXdExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Daiichi Sankyo

Industry Sponsor

Trials
443
Recruited
493,000+
Hiroyuki Okuzawa profile image

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe profile image

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Citations

First Patient Dosed in Study of I-DXd in Esophageal Cancer

the confirmed ORR was 54.8% (95% CI, 38.7%-70.2%) was observed in patients receiving the 12 mg/kg dose (n = 42), with 23 partial responses (PRs ...

Ifinatamab Deruxtecan in Patients With Extensive-Stage Small ...

I-DXd 12 mg/kg once every 3 weeks showed promising efficacy in patients with previously treated ES-SCLC. The observed safety profile was consistent with ...

IDeate-Esophageal01 Phase 3 Trial of Ifinatamab ...

ESCC accounts for nearly 90% of esophageal cancers globally with a five-year overall survival rate around 15% to 20% and has a worse prognosis

NCT06644781 | A Study of Ifinatamab Deruxtecan in ...

This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd) in patients with unresectable advanced or metastatic esophageal ...

A Study of Ifinatamab Deruxtecan in Subjects With ...

This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd) in patients with unresectable advanced or metastatic esophageal ...

690P Ifinatamab deruxtecan (I-DXd; DS-7300) in patients ...

I-DXd continues to demonstrate a manageable safety profile and promising antitumor activity with encouraging DOR and OS in these heavily pretreated patients, ...

IDeate-Esophageal01 Phase 3 Trial of Ifinatamab ...

IDeate-Esophageal01 is a global, multicenter, open-label, randomized Phase 3 trial evaluating the safety and efficacy of ifinatamab deruxtecan (12 mg/kg)

"Ifinatamab deruxtecan (I-DXd; DS-7300) in patients with ...

I-DXd continues to demonstrate a manageable safety profile and promising antitumor activity with encouraging DOR and OS in these heavily pretreated patients.