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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)

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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)

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

Trial contacts and locations

8

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Central trial contact

Reference Study ID Number: GA43861 https://forpatients.roche.com/

Data sourced from clinicaltrials.gov

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