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Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies

NCT04068597 · CellCentric Ltd.
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Official title
An Open-label Phase I/IIa Study to Evaluate the Safety and Efficacy of CCS1477 as Monotherapy and in Combination in Patients With Advanced Haematological Malignancies.
About this study
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 (\> 470 msec)
Study design
Enrollment target: 250 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2019-08-09
Estimated completion: 2027-03-31
Last updated: 2025-12-18
Interventions
Drug: CCS1477Drug: PomalidomideDrug: DexamethasoneDrug: AzacitidineDrug: VenetoclaxDrug: BortezomibDrug: IxazomibDrug: ElranatamabDrug: TeclistamabDrug: LenalidomideDrug: Daratumumab
Primary outcomes
  • Incidence of treatment-related adverse events (Up to 12 months)
  • Incidence of laboratory abnormalities (Up to 12 months)
Sponsor
CellCentric Ltd. · industry
Contacts & investigators
ContactTomasz Knurowski, PhD · contact · Tomasz.Knurowski@cellcentric.com · 07882871299
ContactKaren Clegg, MD, MFPM · contact · Karen.Clegg@cellcentric.com
InvestigatorTim Somervaille · principal_investigator, The Christie NHS Foundation Trust
All locations (39)
Emory Winship Cancer InstituteRecruiting
Atlanta, Georgia, United States
Community Health NetworkRecruiting
Indianapolis, Indiana, United States
The Center for Cancer and Blood Disorders (CCBD)Recruiting
Bethesda, Maryland, United States
Nebraska Cancer SpecialistsRecruiting
Omaha, Nebraska, United States
University of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
Penn Medicine - Abramson Cancer Center PerelmanRecruiting
Philadelphia, Pennsylvania, United States
Institute BergonieCompleted
Bordeaux, France
Gustave RoussyCompleted
Villejuif, France
Hospital Germans Trias i Pujol/ ICO BadalonaRecruiting
Badalona, Spain
University Hospital Vall D'HebronCompleted
Barcelona, Spain
Hospital Clínic de BarcelonaRecruiting
Barcelona, Spain
ICO L'Hospitalet (Instituto Catalán de Oncología)Recruiting
Barcelona, Spain
Hospital Universitario de La PrincesaRecruiting
Madrid, Spain
Hospital Universitario Gregorio MarañónRecruiting
Madrid, Spain
Hospital Infanta LeonorRecruiting
Madrid, Spain
Hospital Universitario Ramón y CajalRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
CIOCC Hospital Universitario HM SanchinarroCompleted
Madrid, Spain
Universidad de NavarraRecruiting
Pamplona, Spain
Hospital Universitario y Politécnico La Fe de la Comunidad ValencianaRecruiting
Valencia, Spain
Karolinska Comprehensive Cancer CenterCompleted
Stockholm, Sweden
The Royal MarsdenRecruiting
Sutton, Surrey, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust,Recruiting
Bebington, United Kingdom
University Hospitals BristolRecruiting
Bristol, United Kingdom
University Hospital of WalesRecruiting
Cardiff, United Kingdom
Royal Derby HospitalRecruiting
Derby, United Kingdom
Western General HospitalRecruiting
Edinburgh, United Kingdom
Gartnavel General HospitalRecruiting
Glasgow, United Kingdom
Leicester Royal InfirmaryRecruiting
Leicester, United Kingdom
St Bartholomew's HospitalRecruiting
London, United Kingdom
Sarah Cannon Research Institute UKRecruiting
London, United Kingdom
NIHR University College London Clinical Research FacilityRecruiting
London, United Kingdom
Imperial CollegeRecruiting
London, United Kingdom
The Christie HospitalRecruiting
Manchester, United Kingdom
Newcastle upon Tyne HospitalsRecruiting
Newcastle upon Tyne, United Kingdom
Nottingham University Hospitals NHS TrustRecruiting
Nottingham, United Kingdom
Cancer and Haematology CentreRecruiting
Oxford, United Kingdom
University Hospital of SouthamptonRecruiting
Southampton, United Kingdom
Royal Stoke University HospitalRecruiting
Stoke-on-Trent, United Kingdom
Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies · TrialPath