Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
I-DXd · 1 trial · 1 indication
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
| Arm | Type | Description |
|---|---|---|
| I-DXd | EXPERIMENTAL | Participants will be administered I-DXd every 3 weeks until progressive disease or discontinuation criteria are met. |
| Name | Type | Description |
|---|---|---|
| I-DXd | BIOLOGICAL | IV Infusion |
| Rescue Medication | DRUG | Includes 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroid, administered per approved product label |
Inclusion Criteria: * Has a histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) * Has disease progression after 1 or 2 prior lines of systemic therapy for unresectable locally advanced or metastatic ESCC * Has ...
I-DXd, also known as ifinatamab deruxtecan, is an investigational monoclonal antibody being studied for the treatment of oesophageal squamous cell carcinoma, a type of advanced esophageal cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
I-DXd is an antibody-drug conjugate that targets a specific antigen on cancer cells, though the exact molecular target has not been disclosed in available information. It is designed to deliver a cytotoxic payload to tumor cells expressing the target, thereby inhibiting cancer growth.
I-DXd is being developed by Merck & Company, Inc., a global biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in early-stage clinical trials for esophageal cancer.
I-DXd is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being evaluated for safety and efficacy in clinical trials.
I-DXd is being studied in a Phase 1 clinical trial with the identifier NCT07405151, titled "A Clinical Trial of Ifinatamab Deruxtecan in People With Advanced Esophageal Cancer (MK-3475-06F)." The trial is currently recruiting participants with oesophageal squamous cell carcinoma across multiple countries.
Yes, I-DXd is also known as ifinatamab deruxtecan. The drug is referred to by both names in clinical research and development contexts, and they refer to the same investigational antibody-drug conjugate.