Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies
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.
1 other identifier
interventional
250
5 countries
39
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2019
Longer than P75 for phase_1
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 9, 2019
CompletedFirst Submitted
Initial submission to the registry
August 12, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
December 18, 2025
December 1, 2025
7.6 years
August 12, 2019
December 17, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of treatment-related adverse events
Treatment-related adverse events and serious adverse events
Up to 12 months
Incidence of laboratory abnormalities
Laboratory abnormalities characterised by type, frequency, severity and timing
Up to 12 months
Secondary Outcomes (4)
Response rate
Up to 12 months
Duration of Response
Up to 12 months
AUC of CCS1477
35 days
Cmax of CCS1477
35 days
Study Arms (6)
CCS1477 dose escalation NHL/MM
EXPERIMENTALCCS1477 monotherapy
CCS1477 dose escalation AML/Higher risk MDS
EXPERIMENTALCCS1477 monotherapy
CCS1477 monotherapy expansion and combination dose finding and expansion NHL
EXPERIMENTALCCS1477 monotherapy, CCS1477 combination with lenalidomide
CCS1477 monotherapy expansion and combination dose finding and expansion - MM
EXPERIMENTALCCS1477 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
CCS1477 monotherapy expansion and combination dose finding and expansion - AML
EXPERIMENTALCCS1477 monotherapy, CCS1477 combination with azacitidine, CCS1477 combination with azacitidine and venetoclax
CCS1477 monotherapy expansion and combination dose finding and expansion - Higher risk MDS
EXPERIMENTALCCS1477 monotherapy, CCS1477 combination with azacitidine
Interventions
Oral capsule
oral capsule
oral tablet
Powder suspension for Injection
Oral tablet
Powder for solution for injection
Oral capsule
Solution for injection
Solution for injection
Oral capsule
Solution for injection, concentrate for solution for infusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CellCentric Ltd.lead
Study Sites (39)
Emory Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Community Health Network
Indianapolis, Indiana, 46227, United States
The Center for Cancer and Blood Disorders (CCBD)
Bethesda, Maryland, 20817, United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-6846, United States
Penn Medicine - Abramson Cancer Center Perelman
Philadelphia, Pennsylvania, 19104, United States
Institute Bergonie
Bordeaux, 33076, France
Gustave Roussy
Villejuif, 94805, France
Hospital Germans Trias i Pujol/ ICO Badalona
Badalona, 08916, Spain
University Hospital Vall D'Hebron
Barcelona, 08035, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
ICO L'Hospitalet (Instituto Catalán de Oncología)
Barcelona, 08908, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital Universitario Gregorio Marañón
Madrid, 28009, Spain
Hospital Infanta Leonor
Madrid, 28031, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
CIOCC Hospital Universitario HM Sanchinarro
Madrid, 28050, Spain
Universidad de Navarra
Pamplona, 31008, Spain
Hospital Universitario y Politécnico La Fe de la Comunidad Valenciana
Valencia, 46026, Spain
Karolinska Comprehensive Cancer Center
Stockholm, Sweden
The Royal Marsden
Sutton, Surrey, SM2 5PT, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust,
Bebington, CH63 4JY, United Kingdom
University Hospitals Bristol
Bristol, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
Royal Derby Hospital
Derby, DE22 3NE, United Kingdom
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Gartnavel General Hospital
Glasgow, G12 0YN, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
St Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
Sarah Cannon Research Institute UK
London, W1G 6AD, United Kingdom
NIHR University College London Clinical Research Facility
London, W1T 7HA, United Kingdom
Imperial College
London, United Kingdom
The Christie Hospital
Manchester, United Kingdom
Newcastle upon Tyne Hospitals
Newcastle upon Tyne, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB, United Kingdom
Cancer and Haematology Centre
Oxford, OX3 7LE, United Kingdom
University Hospital of Southampton
Southampton, SO16 6YD, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tim Somervaille
The Christie NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2019
First Posted
August 28, 2019
Study Start
August 9, 2019
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
December 18, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share
At this stage, is not currently planned that any IPD information will be shared with other researchers outside of the Sponsor and Clinical Research Organisations involved in the conduct of this study.