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.
Who is this study for? Patients with Hematological Malignancies
What treatments are being studied? CCS1477
Status: Recruiting
Location: See all (39) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Georgia
Emory Winship Cancer Institute
RECRUITING
Atlanta
Indiana
Community Health Network
RECRUITING
Indianapolis
Maryland
The Center for Cancer and Blood Disorders (CCBD)
RECRUITING
Bethesda
Nebraska
Nebraska Cancer Specialists
RECRUITING
Omaha
University of Nebraska Medical Center
RECRUITING
Omaha
Pennsylvania
Penn Medicine - Abramson Cancer Center Perelman
RECRUITING
Philadelphia
Other Locations
France
Institute Bergonie
COMPLETED
Bordeaux
Gustave Roussy
COMPLETED
Villejuif
Spain
Hospital Germans Trias i Pujol/ ICO Badalona
RECRUITING
Badalona
Hospital Clínic de Barcelona
RECRUITING
Barcelona
ICO L'Hospitalet (Instituto Catalán de Oncología)
RECRUITING
Barcelona
University Hospital Vall D'Hebron
COMPLETED
Barcelona
CIOCC Hospital Universitario HM Sanchinarro
COMPLETED
Madrid
Hospital Infanta Leonor
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario de La Princesa
RECRUITING
Madrid
Hospital Universitario Gregorio Marañón
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Universidad de Navarra
RECRUITING
Pamplona
Hospital Universitario y Politécnico La Fe de la Comunidad Valenciana
RECRUITING
Valencia
Sweden
Karolinska Comprehensive Cancer Center
COMPLETED
Stockholm
United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust,
RECRUITING
Bebington
University Hospitals Bristol
RECRUITING
Bristol
University Hospital of Wales
RECRUITING
Cardiff
Royal Derby Hospital
RECRUITING
Derby
Western General Hospital
RECRUITING
Edinburgh
Gartnavel General Hospital
RECRUITING
Glasgow
Leicester Royal Infirmary
RECRUITING
Leicester
Imperial College
RECRUITING
London
NIHR University College London Clinical Research Facility
RECRUITING
London
Sarah Cannon Research Institute UK
RECRUITING
London
St Bartholomew's Hospital
RECRUITING
London
The Christie Hospital
RECRUITING
Manchester
Newcastle upon Tyne Hospitals
RECRUITING
Newcastle Upon Tyne
Nottingham University Hospitals NHS Trust
RECRUITING
Nottingham
Cancer and Haematology Centre
RECRUITING
Oxford
University Hospital of Southampton
RECRUITING
Southampton
Royal Stoke University Hospital
RECRUITING
Stoke-on-trent
The Royal Marsden
RECRUITING
Sutton
Contact Information
Primary
Tomasz Knurowski, PhD
Tomasz.Knurowski@cellcentric.com
07882871299
Backup
Karen Clegg, MD, MFPM
Karen.Clegg@cellcentric.com
Time Frame
Start Date: 2019-08-09
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 250
Treatments
Experimental: CCS1477 dose escalation NHL/MM
CCS1477 monotherapy
Experimental: CCS1477 dose escalation AML/Higher risk MDS
CCS1477 monotherapy
Experimental: CCS1477 monotherapy expansion and combination dose finding and expansion NHL
CCS1477 monotherapy, CCS1477 combination with lenalidomide
Experimental: CCS1477 monotherapy expansion and combination dose finding and expansion - MM
CCS1477 monotherapy, CCS1477 combination with pomalidomide-dexamethasone, CCS1477 combination with bortezomib-dexamethasone, CCS1477 combination with ixazomib-dexamethasone, CCS1477 combination with elranatamab, CCS1477 combination with teclistamab, CCS1477 combination with lenalidomide, CCS1477 combination with lenalidomide and daratumumab
Experimental: CCS1477 monotherapy expansion and combination dose finding and expansion - AML
CCS1477 monotherapy, CCS1477 combination with azacitidine, CCS1477 combination with azacitidine and venetoclax
Experimental: CCS1477 monotherapy expansion and combination dose finding and expansion - Higher risk MDS
CCS1477 monotherapy, CCS1477 combination with azacitidine
Authors
Related Therapeutic Areas
Sponsors
Leads: CellCentric Ltd.