Acute graft-versus-host disease Surgery
Conditions
Interventions
GCD-8264, 35 mg: Participants will receive standard-of care (SOC) treatment with prednisone =2 milligram per kilogram per day (mg/kg/day), orally (PO), or methylprednisolone =2 mg/kg/day, intravenousl
Sponsors
Genentech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed Informed Consent Form (ICF) from the participant or legal representative 2. Age =18 years at time of signing ICF 3. Diagnosis of post-allogeneic hematopoietic stem cell transplantation (HSCT) aGVHD at screening, with the following aspects of HSCT permissible: 3.1. Any malignant or non-malignant indication leading to HSCT 3.2. Any HSCT donor type (e.g., related, unrelated) or stem cell source (i.e., bone marrow, peripheral blood, cord blood) 3.3. Any GVHD prophylaxis regimen 3.4. Any conditioning regimen (i.e., myeloablative, reduced intensity, and non-myeloablative) 4. Evidence of engraftment post-transplant 5. Diagnosis of high-risk aGVHD, per refined Minnesota high-risk aGVHD criteria during screening 6. Initiation of treatment with systemic corticosteroids for aGVHD at a dose of prednisone =2 mg/kg/day 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
Exclusion criteria
Exclusion criteria: 1. Evidence of relapsed, progressing, or persistent malignancy, or treatment for relapse after transplant, or requirement for rapid immune suppression withdrawal as pre-emergent treatment of early malignancy relapse 2. Prior receipt of more than one allogeneic HSCT 3. Prior systemic treatment for aGVHD, except for the standard of care corticosteroid treatment initiated as part of this trial 4. Diagnosis of chronic GVHD or overlap syndrome 5. Uncontrolled active infection (i.e., progressive symptoms related to infection despite treatment, or persistently positive blood cultures despite treatment, or any other evidence of severe sepsis) 6. Severe organ dysfunction (e.g., acute liver failure, renal failure requiring dialysis, ventilator support, or vasopressor therapy) 7. Initiation or planned use of a marketed small molecule (excluding corticosteroids) or biologic therapy as treatment for aGVHD from the start of screening through the treatment period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured using patient records: 1. Percentage of Participants with Adverse Events (AEs) and Severity of AEs Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Collected from Screening up to End of Study (Up to Approximately 3 years) 2. Plasma Concentration and Relevant PK Parameters of GDC-8264 Measured from Blood Samples Collected at Pre-dose and Multiple Timepoints Post-dose up to Day 57 | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured using patient records: 1. Objective Response Rate (ORR), as Determined by the Investigator From Initiation of Study Treatment to Day 29 2. Duration of Response (DOR), as Determined by the Investigator From Day 29 up to End of Study (Approximately 3 years) 3. Percentage of Participants with Acute Graft-versus-host Disease (aGVHD) Flares, Defined as an Increase in Target Organ Staging For At Least 3 Days Requiring Additional Treatment as Assessed by Clinical Examination, From Initiation of Study Treatment up to Day 56 4. Percentage of Participants with Non-relapse Mortality (NRM) From Initiation of Study Treatment up to Day 180 | — |
Countries
United States of America
Contacts
Public ContactClinical Trials
Outcome results
None listed