Assess safety, tolerability and preliminary efficacy of FP-1305 in haematological malignancies + SOC

• Research type

  Research Study

• Full title

  A Phase I/II Open-Label Study to Assess Safety, Tolerability and Preliminary Efficacy of the Clever-1 Antibody Bexmarilimab in Combination with Standard of Care Therapy in Patients with Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia or Acute Myeloid Leukemia

• IRAS ID

  1010884

• Contact name

  Joab Williamson

• Contact email

  Joab.williamson@faron.com

• Sponsor organisation

  Faron Pharmaceuticals Ltd.

• Eudract number

  2021-002104-12

• Clinicaltrials.gov Identifier

  NCT05428969

• Research summary

  This is a multicentre Phase 1/2 open-label, study to assess the safety, tolerability and preliminary efficacy of increasing doses of bexmarilimab (FP-1305) in patients with intermediate, high or very high-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) with 10-19 % marrow blasts, CMML/MDS with failure to hypomethylating agent (HMA) treatment, or in patients with newly diagnosed Acute Myeloid Leukaemia (AML) non-fit for induction therapy or relapsed/refractory AML. 
  The Phase 1 part of the study will identify a safe and tolerable bexmarilimab dose from four predefined dose levels to identify the maximum tolerated dose (MTD) or if not reached, the recommended dose for expansion (RDE), of bexmarilimab when administered in combination with standard of care treatment (SoC). 
  The Phase 2 of the study is an expansion phase to further evaluate the safety and preliminary efficacy of bexmarilimab treatment at the recommended dose level and one dose level below RDE that will be taken into phase 2 combined with SoC .
  Both study phases consist of a screening period, a treatment period, an end of treatment (EoT) as safety follow-up and disease progression/survival follow-up .
  The study drug will be administered in combination with standard of care therapy, azacitidine or standard of care therapy, azacitidine and venetoclax. Azacitidine is administered in every treatment cycle on Days 1-7 as subcutaneous injection. Venetoclax is administered orally on Day 1-28 of each cycle. 
  A safety follow-up visit will occur 30 days after permanently discontinuing the study drug. 
  A Disease Progression Follow up will be every 3 months from the start of study treatment for 24 months. 

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  24/LO/0788

• Date of REC Opinion

  29 Nov 2024

• REC opinion

  Further Information Favourable Opinion