Status and phase
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This is a Phase 1, open label, two-part study to determine recommended phase 2 dose (RP2D) and schedule of GSK3745417 administration in participants with relapsed/refractory AML or HR-MDS.
Enrollment
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Volunteers
Inclusion criteria
Participants must be ≥18 years of age and ≤75 years of age at the time of signing the informed consent for dose escalation and >18 years of age at the time of signing the informed consent for the dose expansion.
Participants must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Participants with AML/HR MDS are eligible for participation in Part 1 and Part 2 if they have:
Participants with a prior history of stem cell transplant (autologous and/or allogeneic) are allowed if:
No clinical signs or symptoms of graft versus host disease (other than Grade 1 GVHD (<25% skin surface affected) and the participant is off all systemic immunosuppression. (Note: topical steroids for G1 skin GVHD are permitted on study)
Female participants are eligible to participate if they are not either pregnant or breastfeeding, and at least one of the following conditions applies:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
18 participants in 2 patient groups
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Central trial contact
US GSK Clinical Trials Call Center; EU GSK Clinical Trials Call Center
Data sourced from clinicaltrials.gov
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