Ifinatamab Deruxtecan for Esophageal Cancer
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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants will be administered I-DXd every 3 weeks until progressive disease or discontinuation criteria are met
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Participants will be administered I-DXd every 3 weeks until progressive disease or discontinuation criteria are met.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
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
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
Hiroyuki Okuzawa
Daiichi Sankyo
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University
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.
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