Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GDC-8264 · 1 trial · 1 indication
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Plasma concentration of GDC-8264 at specified timepoints was determined.
Steady-state (SS) PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.
SS PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.
SS PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.
SS PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.
SS PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.
SS PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.
| Arm | Type | Description |
|---|---|---|
| GDC-8264, 35 mg | EXPERIMENTAL | Participants will receive oral GDC-8264, 35 milligrams (mg), once daily (QD) for 28 days. |
| GDC-8264, 75 mg | EXPERIMENTAL | Participants will receive oral GDC-8264, 75 mg, PO, QD for 28 days. |
| Name | Type | Description |
|---|---|---|
| GDC-8264 | DRUG | GDC-8264 tablets will be administered as per the schedule specified in the respective arms. |
Inclusion Criteria: * Diagnosis of post-allogeneic hematopoietic stem cell transplantation (HSCT) aGVHD at screening * Evidence of engraftment post-transplant * Diagnosis of high-risk aGVHD, per refined Minnesota high-risk aGVHD criteria during screening * Initiation of treatment with systemic cort...
GDC-8264 is an investigational small molecule being developed for the treatment of acute Graft-versus-host Disease (aGVHD). It is intended to be used in combination with standard of care therapy in patients with this condition. The drug is currently in Phase 1 clinical development.
GDC-8264 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of this investigational drug in patients with acute Graft-versus-host Disease.
GDC-8264 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 1 study has been completed to assess its safety and pharmacokinetics in combination with standard of care for acute Graft-versus-host Disease.
GDC-8264 has one completed clinical trial, identified as NCT05673876. This Phase 1 study assessed the safety and pharmacokinetics of GDC-8264 in combination with standard of care in participants with acute Graft-versus-host Disease. The trial enrolled 7 participants in the United States.
GDC-8264 is the primary name for this investigational small molecule. No alternative names have been reported for this drug in the available clinical trial information. It is being studied specifically for acute Graft-versus-host Disease.