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Also known as DS-8201a
DS-8201a/kg Q3W · 1 trial · 1 indication
Confirmed objective response rate (ORR), defined as the number (percentage) of participants with complete response (CR) or partial response (PR), were assessed by blinded independent central review (BICR) based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
| Arm | Type | Description |
|---|---|---|
| T-DXd 5.4 mg/kg Q3W | EXPERIMENTAL | Participants will be randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W). |
| T-DXd 6.4 mg/kg Q3W | EXPERIMENTAL | Participants will be randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W). |
| Name | Type | Description |
|---|---|---|
| DS-8201a 5.4 mg/kg Q3W | DRUG | DS-8201a for injection will be administered intravenously (IV) at a dose of 5.4 mg/kg every 3 weeks (Q3W) |
| DS-8201a 6.4 mg/kg Q3W | DRUG | DS-8201a for injection will be administered intravenously (IV) at a dose of 6.4 mg/kg every 3 weeks (Q3W) |
KEY Inclusion Criteria: Participants must meet all of the following criteria to be eligible for randomization/registration into the study: 1. Adults aged ≥20 years in Japan, Taiwan, and Korea, or those aged ≥18 years in other countries, at the time the Informed Consent Forms (ICFs) are signed. 2. ...
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DS-8201a is an investigational oncology drug being studied for colorectal neoplasms, advanced colorectal cancer, advanced solid tumors, and HER2-positive primary breast cancer. It is a small molecule in clinical development for these cancer indications.
DS-8201a is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various cancer types.
DS-8201a is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness.
DS-8201a has been studied in several clinical trials, including NCT02564900 for advanced solid tumors, NCT03384940 for HER2-expressing colorectal cancer, NCT04622319 for HER2-positive breast cancer, and NCT04744831 for advanced colorectal cancer.
DS-8201a is also known as trastuzumab deruxtecan (T-DXd). Clinical trials such as NCT04622319 and NCT04744831 refer to the drug by this alternative name, confirming that DS-8201a and trastuzumab deruxtecan are the same compound.
DS-8201a clinical trials have enrolled a total of 1,600 participants across multiple studies. The largest trial, NCT04622319, has an enrollment of 1,600 participants, while other trials have smaller cohorts ranging from 86 to 292 participants.