Study to Evaluate CCS1477 (inobrodib) in Haematological Malignancies

Sponsor: CellCentric Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04068597

Patient View

This Phase 1/2a study evaluates CCS1477's safety and biological activity in patients with relapsed or refractory haematological malignancies, including Peripheral T-cell lymphoma. Eligible participants must have an ECOG status of 0-2, confirmed diagnosis, prior standard therapy, and adequate organ function. Interventions include CCS1477, Pomalidomide, Dexamethasone, Azacitidine, and Venetoclax.

Patient Parameters

Program Overview

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

Description

This includes patients with Peripheral T-cell lymphoma.

Eligibility Criteria

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)

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