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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)

Status
Completed
Cancer Type
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05673876
Protocol IDs
GA43861 (primary)
NCI-2023-00306
ISRCTN27200385
Study Sponsor
Genentech Inc.

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).

Eligibility

  1. Diagnosis of post-allogeneic hematopoietic stem cell transplantation (HSCT) aGVHD at screening
  2. Evidence of engraftment post-transplant
  3. Diagnosis of high-risk aGVHD, per refined Minnesota high-risk aGVHD criteria during screening
  4. Initiation of treatment with systemic corticosteroids for aGVHD at a dose of prednisone =2 milligrams per kilograms per day (mg/kg/day) by orally (PO) or methylprednisolone =2 mg/kg/day intravenously (or equivalent) in divided doses at diagnosis and up to 3 days prior to or on the same day as initiation of GDC-8264 (Day 1), with no taper planned prior to Day 3

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.