Study to Evaluate CCS1477 in Haematological Malignancies

 Haematology / Posted 3 weeks ago

A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome.

  • Inclusion Criteria :
    • Provision of consent
    • ECOG performance status 0-2
    • Patients with confirmed (per standard disease specific diagnostic criteria), relapsed or refractory haematological malignancies (NHL, MM and AML)
    • Must have previously received standard therapy
    • Adequate organ function
  • Exclusion Criteria :
    • Intervention with any chemotherapy, investigational agents or other anti-cancer drugs within 14 days or 5 half-lives of the first dose
    • Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study treatment
    • Strong inhibitors of CYP3A4 or CYP3A4 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment
    • Strong inducers of CYP3A4 within 4 weeks of the first dose of study treatment
    • Patients should discontinue statins prior to starting study treatment
    • CYP2C8 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment
    • Any unresolved reversible toxicities from prior therapy >CTCAE grade 1 at the time of starting study treatment (except alopecia and grade 2 neuropathy)
    • Any evidence of severe or uncontrolled systemic diseases
    • Any known uncontrolled inter-current illness QTcF prolongation (> 480 msec)
  • Study end date : 31/12/2021
  • Wales-Based Study Contact : Steven Knapper - University Hospital Wales
  • Principal Investigator : Tim Somervaille - The Christie NHS Foundation Trust

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