NCT05673876

A Study to Assess the Safety and Pharmacokinetics of GDC-8264 in Combination With Standard of Care in Participants With Acute Graft-Versus-Host Disease (aGVHD)

A Phase Ib, Open-label, Randomized, Dose-finding, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of GDC-8264 in Combination With Standard of Care in the Treatment of Acute Graft-versus-Host Disease in Patients Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the study is to assess the safety and pharmacokinetics (PK) of GDC-8264 in participants with acute graft-versus-host disease (aGVHD).

Conditions

• Acute Graft-versus-host Disease

Interventions

Type	Name	Description
DRUG	GDC-8264	GDC-8264 tablets will be administered as per the schedule specified in the respective arms.

Timeline

• Start date: 2023-04-06
• Primary completion: 2024-01-15
• Completion: 2024-01-15
• First posted: 2023-01-06
• Last updated: 2025-05-28
• Results posted: 2025-04-24

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study