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GDC-0623 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| GDC-0623 | DRUG | Repeating oral dose |
Inclusion Criteria: * Histologically or cytologically documented, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable * Evaluable disease or disease measurable per RECIST * Life expectancy \>= 12 weeks * Adequate hema...
GDC-0623 is an investigational small molecule being studied for the treatment of locally advanced or metastatic solid tumors. It has been evaluated in a Phase 1 clinical trial in adult patients with solid cancers. It is not an approved therapy and remains in clinical development.
GDC-0623 is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche conducted the Phase 1 study of the compound in patients with solid tumors.
GDC-0623 is in Phase 1 development. One Phase 1 trial has been completed, and there are currently no active trials listed for the drug. It is an investigational agent and has not been approved for any indication.
GDC-0623 has been studied in a single Phase 1 trial, NCT01106599, titled A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0623 in Patients With Locally Advanced or Metastatic Solid Tumors. The trial enrolled 61 patients in the United States and has been completed.
No, GDC-0623 is not FDA approved. It is an investigational small molecule that has completed a Phase 1 clinical trial in solid tumors. Approval status has not been granted for any indication.