Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies

Last updated: May 12, 2025
Sponsor: CellCentric Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Acute Myeloid Leukemia

Lymphoma

Neoplasms

Treatment

Pomalidomide

Azacitidine

Venetoclax

Clinical Study ID

NCT04068597
CCS1477-02
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Intervention with any chemotherapy, investigational agents or other anti-cancerdrugs within 14 days or 5 half-lives of the first dose

  • Major surgical procedure or significant traumatic injury within 4 weeks of the firstdose of study treatment

  • Strong inhibitors of CYP3A4 or CYP3A4 substrates with a narrow therapeutic rangetaken 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 firstdose of study treatment

  • Any unresolved reversible toxicities from prior therapy >CTCAE grade 1 at the timeof 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 Design

Total Participants: 250
Treatment Group(s): 5
Primary Treatment: Pomalidomide
Phase: 1/2
Study Start date:
August 09, 2019
Estimated Completion Date:
March 31, 2027

Study Description

This includes patients with Peripheral T-cell lymphoma.

Connect with a study center

  • Institute Bergonie

    Bordeaux, 33000
    France

    Site Not Available

  • Institute Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

  • University Hospital Vall D'Hebron

    Barcelona, 08035
    Spain

    Completed

  • CIOCC Hospital Universitario HM Sanchinarro

    Madrid, 28050
    Spain

    Completed

  • Karolinska Institute

    Stockholm, 171 76
    Sweden

    Site Not Available

  • The Royal Marsden

    Sutton, Surrey SM2 5PT
    United Kingdom

    Active - Recruiting

  • The Clatterbridge Cancer Centre NHS Foundation Trust,

    Bebington, CH63 4JY
    United Kingdom

    Active - Recruiting

  • University Hospitals Bristol

    Bristol,
    United Kingdom

    Active - Recruiting

  • University Hospital of Wales

    Cardiff,
    United Kingdom

    Active - Recruiting

  • Royal Derby Hospital

    Derby, DE22 3NE
    United Kingdom

    Active - Recruiting

  • Western General Hospital

    Edinburgh, EH4 2XU
    United Kingdom

    Active - Recruiting

  • Gartnavel General Hospital

    Glasgow, G12 0YN
    United Kingdom

    Active - Recruiting

  • Leicester Royal Infirmary

    Leicester,
    United Kingdom

    Active - Recruiting

  • Imperial College

    London,
    United Kingdom

    Active - Recruiting

  • NIHR University College London Clinical Research Facility

    London, W1T 7HA
    United Kingdom

    Active - Recruiting

  • Sarah Cannon Research Institute UK

    London, W1G 6AD
    United Kingdom

    Active - Recruiting

  • The Christie Hospital

    Manchester,
    United Kingdom

    Active - Recruiting

  • Newcastle upon Tyne Hospitals

    Newcastle upon Tyne,
    United Kingdom

    Active - Recruiting

  • Cancer and Haematology Centre

    Oxford,
    United Kingdom

    Active - Recruiting

  • University Hospital of Southampton

    Southampton, SO16 6YD
    United Kingdom

    Active - Recruiting

  • Mayo Clinic

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Emory Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Community Health Network

    Indianapolis, Indiana 46227
    United States

    Active - Recruiting

  • The Center for Cancer and Blood Disorders (CCBD)

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraska 68130
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198-6846
    United States

    Active - Recruiting

  • Penn Medicine - Abramson Cancer Center Perelman

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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