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TAK-165 · 1 trial · 5 indications
| Arm | Type | Description |
|---|---|---|
| TAK-165 QD | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| TAK-165 | DRUG | Starting dose of TAK-165 10 mg, tablets, orally, once daily with dose escalation to tolerability for 56 days. |
Inclusion Criteria: * Have advanced or metastatic cancer which is refractory to standard therapy or subjects for whom there is no known effective therapy. * Have a histologically or cytologically proven diagnosis of a solid tumor known to express HER2. * Have a predicted life expectancy of greater ...
TAK-165 is an investigational small molecule developed for the treatment of breast neoplasm and other solid tumors. It was studied in subjects with tumors expressing HER2, including breast, pancreatic, lung, ovarian, and renal neoplasms. It is not approved and remains in clinical development.
TAK-165 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical program for this asset.
TAK-165 is in Phase 1 clinical development. It has completed one Phase 1 trial and has no active trials. The drug is investigational and has not been approved for any indication.
TAK-165 has been evaluated in one completed Phase 1 trial, NCT00034281, titled Safety and Tolerability Study of TAK-165 in Subjects With Tumors Expressing HER2. The trial enrolled 16 participants in the United States and included breast, pancreatic, lung, ovarian, and renal neoplasms.
Yes, TAK-165 was studied in a biomarker-selected population. The Phase 1 trial NCT00034281 enrolled subjects with tumors expressing HER2, indicating that HER2 expression was used to select patients for the study.