A Phase 1b/2 Study of KRT-232 in Patients with Acute Myeloid Leukemia
Research type
Research Study
Full title
An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined with Low-Dose Cytarabine (LDAC) or Decitabine in Patients with Acute Myeloid Leukemia (AML)
IRAS ID
270645
Contact name
Steven Knapper
Contact email
Sponsor organisation
Kartos Therapeutics, Inc.
Eudract number
2019-001201-24
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 10 months, days
Research summary
This phase 1b study will test an investigational drug called KRT-232 for the potential treatment of Acute Myeloid Leukaemia (AML). The protocol is for phase 1b/2 but this submission is for the phase 1b only. Phase 2 part will be completed in a separate submission.
KRT-232 is a tablet that is taken by mouth with water. This study will determine if this drug is able to reduce the growth of unhealthy or tumour cells, and help restore the function of bone marrow. The study drug will be given to participants along with another approved therapy for Acute Myeloid Leukemia (AML) assigned by your study doctor. This other therapy will be either cytarabine (injected under the skin) or decitabine (injected into a vein).
Approximately 85 global sites are planned with up to approximately between 18 and 120 participants will be enrolled in Part A.
Participants will be aged over 18 years and will be seen in a hospital setting. The study will be considered complete 2 years after the last participant is enrolled, at which time participants will be evaluated for eligibility - Phase 2 - Part B
REC name
South West - Central Bristol Research Ethics Committee
REC reference
19/SW/0185
Date of REC Opinion
12 Nov 2019
REC opinion
Further Information Favourable Opinion