Study on Ifinatamab Deruxtecan for Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
Sponsor: Daiichi Sankyo
ClinicalTrials ID:NCT06644781
This clinical trial is testing a new drug, ifinatamab deruxtecan (I-DXd), to see if it can help patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have not responded to previous treatments. The study compares I-DXd with standard chemotherapy options chosen by the doctor.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to find out if the new drug ifinatamab deruxtecan (I-DXd) can help people with advanced or metastatic esophageal squamous cell carcinoma (ESCC) live longer compared to standard chemotherapy treatments. The study will also look at how long patients live without the cancer getting worse and how many patients see their tumors shrink with I-DXd compared to standard treatments.
Description
The main goal of this study is to see if ifinatamab deruxtecan (I-DXd) can help patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) live longer compared to standard chemotherapy options chosen by their doctor. The study will also look at how long patients can live without their cancer getting worse and how many patients experience tumor shrinkage with I-DXd compared to standard treatments. Participants will be randomly assigned to receive either I-DXd or a chemotherapy treatment chosen by their doctor. The study will monitor the safety and effectiveness of I-DXd in these patients.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of advanced or metastatic esophageal squamous cell carcinoma (ESCC) that cannot be removed by surgery.
- The cancer must have gotten worse after treatment with a platinum-based chemotherapy and an immune checkpoint inhibitor, with no more than one previous line of treatment for advanced or metastatic ESCC.
- Must provide a tumor sample for testing.
- Have at least one tumor that can be measured by scans, which has not been treated with radiation unless it has shown significant growth.
- Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Exclusion Criteria
- Have received previous treatment with ifinatamab deruxtecan or similar drugs targeting B7-H3.
- Have received any topoisomerase inhibitor.
- Have a different type of esophageal cancer called adenosquamous carcinoma.
- Cannot receive any of the chemotherapy options in the study due to previous issues.
- Have cancer that has spread to nearby organs like the aorta or respiratory tract, increasing the risk of bleeding or fistula.
- Have active or untreated brain metastases or other serious brain conditions requiring treatment.
- Have had a stroke, mini-stroke, or blood clot in the past 6 months.
- Have serious eye disease affecting the cornea.
- Have a history of lung disease requiring steroids or current lung issues that cannot be ruled out.
- Have severe lung problems from other illnesses or need supplemental oxygen.
- Are on long-term steroid treatment, except for low-dose inhaled or topical steroids.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Henry Ford Health System | 48202 | Detroit | Michigan |
| Baptist Cancer Center | 38120 | Memphis | Tennessee |
| John Peter Smith Hospital | 76104 | Fort Worth | Texas |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.