CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 7 enrolled
Drug / intervention
GDC-8264drug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Post-allogeneic HSCT acute GVHD confirmed at screening
  • ✓Evidence of engraftment post-transplant
  • ✓High-risk aGVHD per refined Minnesota criteria at screening
  • ✓Systemic corticosteroid initiation at ≥2 mg/kg/day prednisone PO or ≥2 mg/kg/day methylprednisolone IV (or equivalent) in divided doses, started at diagnosis through 3 days prior to or same day as GDC-8264 initiation (Day 1), with no taper planned prior to Day 3
Key exclusion· 8
  • ✕Relapsed, progressing, or persistent malignancy, or treatment for relapse post-transplant, or requirement for rapid immune suppression withdrawal as pre-emergent treatment of early malignancy relapse
  • ✕Prior receipt of more than one allogeneic HSCT
  • ✕Prior solid organ transplantation that are target organs for aGVHD (e.g., liver transplant)
  • ✕Prior systemic treatment for aGVHD, except corticosteroids initiated as part of this trial

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05673876
NCT05673876Phase 1Completed
CompareCT.gov

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

Genentech, Inc.·interventional·Posted Jan 6, 2023·Updated May 28, 2025

In Brief

A Phase 1 clinical trial evaluating GDC-8264 for Acute Graft-versus-host Disease. Completed, enrolled 7 participants across 4 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Graft-versus-host Disease
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedJan 6, 2023
Enrollment StartApr 6, 2023
Primary CompletionJan 15, 2024
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.5 years ago

Interventions

GDC-8264drug

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