RecruitingPhase 1Phase 2NCT04068597

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.

Sponsor

CellCentric Ltd.

Enrollment

250 participants

Start Date

Aug 9, 2019

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia Haematological Malignancy

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called inobrodib (CCS1477) in people with blood cancers — including non-Hodgkin lymphoma, multiple myeloma, and acute myeloid leukemia — that have returned or are not responding to standard treatment. The drug works by targeting proteins that regulate how genes are turned on and off in cancer cells. **You may be eligible if...** - You have been diagnosed with non-Hodgkin lymphoma, multiple myeloma, or acute myeloid leukemia that has relapsed or is refractory (not responding to treatment) - You have already received standard cancer therapy - You are in reasonably good health (ECOG performance status 0–2) - Your major organs (liver, kidneys, heart) are functioning adequately **You may NOT be eligible if...** - You received chemotherapy or another cancer treatment within the last 14 days or 5 half-lives of that drug - You had major surgery or a serious injury within the past 4 weeks - You are taking certain medications that strongly interact with CYP3A4 enzymes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCCS1477

Oral capsule

DRUGPomalidomide

oral capsule

DRUGDexamethasone

oral tablet

DRUGAzacitidine

Powder suspension for Injection

DRUGVenetoclax

Oral tablet

DRUGBortezomib

Powder for solution for injection

DRUGIxazomib

Oral capsule

DRUGElranatamab

Solution for injection

DRUGTeclistamab

Solution for injection

DRUGLenalidomide

Oral capsule

DRUGDaratumumab

Solution for injection, concentrate for solution for infusion

Locations(39)

Emory Winship Cancer Institute

Atlanta, Georgia, United States

Community Health Network

Indianapolis, Indiana, United States

The Center for Cancer and Blood Disorders (CCBD)

Bethesda, Maryland, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Penn Medicine - Abramson Cancer Center Perelman

Philadelphia, Pennsylvania, United States

Institute Bergonie

Bordeaux, France

Gustave Roussy

Villejuif, France

Hospital Germans Trias i Pujol/ ICO Badalona

Badalona, Spain

University Hospital Vall D'Hebron

Barcelona, Spain

Hospital Clínic de Barcelona

Barcelona, Spain

ICO L'Hospitalet (Instituto Catalán de Oncología)

Barcelona, Spain

Hospital Universitario de La Princesa

Madrid, Spain

Hospital Universitario Gregorio Marañón

Madrid, Spain

Hospital Infanta Leonor

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

CIOCC Hospital Universitario HM Sanchinarro

Madrid, Spain

Universidad de Navarra

Pamplona, Spain

Hospital Universitario y Politécnico La Fe de la Comunidad Valenciana

Valencia, Spain

Karolinska Comprehensive Cancer Center

Stockholm, Sweden

The Royal Marsden

Sutton, Surrey, United Kingdom

The Clatterbridge Cancer Centre NHS Foundation Trust,

Bebington, United Kingdom

University Hospitals Bristol

Bristol, United Kingdom

University Hospital of Wales

Cardiff, United Kingdom

Royal Derby Hospital

Derby, United Kingdom

Western General Hospital

Edinburgh, United Kingdom

Gartnavel General Hospital

Glasgow, United Kingdom

Leicester Royal Infirmary

Leicester, United Kingdom

St Bartholomew's Hospital

London, United Kingdom

Sarah Cannon Research Institute UK

London, United Kingdom

NIHR University College London Clinical Research Facility

London, 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, United Kingdom

Cancer and Haematology Centre

Oxford, United Kingdom

University Hospital of Southampton

Southampton, United Kingdom

Royal Stoke University Hospital

Stoke-on-Trent, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04068597

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