A Phase I/IIa, Open-Label Dose Escalation and Dose Expansion Study of Intravenous GFH009 Single Agent and in Combination With Venetoclax and Azacitidine in Patients With Relapsed/Refractory Hematologic Malignancies
Latest Information Update: 17 Jul 2024
At a glance
- Drugs SLS 009 (Primary) ; Azacitidine; Venetoclax
- Indications Acute myeloid leukaemia; Chronic lymphocytic leukaemia; Haematological malignancies; Lymphoma
- Focus Adverse reactions; First in man
- Sponsors Sellas Life Sciences Group
- 08 Jul 2024 According to a Sellas Life Sciences Group media release, the company received Orphan Drug Designation (ODD) for SLS009 from European Medicines Agency for the treatment of acute myeloid leukemia (AML),supported by phase 2 data from this trail
- 05 Jun 2024 Planned number of patients changed from 135 to 160.
- 05 Jun 2024 Planned End Date changed from 30 Jun 2024 to 31 Dec 2025.