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)

Genentech

Status and phase: Terminated; Phase 1

Conditions: Acute Graft-versus-host Disease

Treatments: Drug: GDC-8264

Study type: Interventional

Funder types: Industry

Identifiers

NCT05673876

ISRCTN27200385 (Other Identifier)

GA43861

Details and patient eligibility

About

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).

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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

Exclusion criteria

• 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
• Prior receipt of more than one allogeneic HSCT
• Prior receipt of solid organ transplantation that are target organs for aGVHD (e.g., liver transplant)
• Prior systemic treatment for aGVHD, except for the standard of care corticosteroid treatment initiated as part of this trial
• Diagnosis of chronic GVHD or overlap syndrome
• 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)
• Severe organ dysfunction (e.g., acute liver failure, renal failure requiring dialysis, ventilator support, or vasopressor therapy)
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

GDC-8264, 35 mg

Experimental group

Description:

Participants will receive oral GDC-8264, 35 milligrams (mg), once daily (QD) for 28 days.

Treatment:

Drug: GDC-8264

GDC-8264, 75 mg

Experimental group

Description:

Participants will receive oral GDC-8264, 75 mg, PO, QD for 28 days.

Treatment:

Drug: GDC-8264