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Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies

NCT ID: NCT04068597

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-09

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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This includes patients with Peripheral T-cell lymphoma.

Conditions

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Haematological Malignancy Acute Myeloid Leukemia Non Hodgkin Lymphoma Multiple Myeloma Higher-risk Myelodysplastic Syndrome Peripheral T Cell Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

The RP2D/MTD dose will be determined in Parts A and B. Parts C, D, E and F of the study may recruit patients concurrently.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CCS1477 dose escalation NHL/MM

CCS1477 monotherapy

Group Type EXPERIMENTAL

CCS1477

Intervention Type DRUG

Oral capsule

CCS1477 dose escalation AML/Higher risk MDS

CCS1477 monotherapy

Group Type EXPERIMENTAL

CCS1477

Intervention Type DRUG

Oral capsule

CCS1477 monotherapy expansion and combination dose finding and expansion NHL

CCS1477 monotherapy, CCS1477 combination with lenalidomide

Group Type EXPERIMENTAL

CCS1477

Intervention Type DRUG

Oral capsule

Lenalidomide

Intervention Type DRUG

Oral capsule

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

Group Type EXPERIMENTAL

CCS1477

Intervention Type DRUG

Oral capsule

Pomalidomide

Intervention Type DRUG

oral capsule

Dexamethasone

Intervention Type DRUG

oral tablet

Bortezomib

Intervention Type DRUG

Powder for solution for injection

Ixazomib

Intervention Type DRUG

Oral capsule

Elranatamab

Intervention Type DRUG

Solution for injection

Teclistamab

Intervention Type DRUG

Solution for injection

Lenalidomide

Intervention Type DRUG

Oral capsule

Daratumumab

Intervention Type DRUG

Solution for injection, concentrate for solution for infusion

CCS1477 monotherapy expansion and combination dose finding and expansion - AML

CCS1477 monotherapy, CCS1477 combination with azacitidine, CCS1477 combination with azacitidine and venetoclax

Group Type EXPERIMENTAL

CCS1477

Intervention Type DRUG

Oral capsule

Azacitidine

Intervention Type DRUG

Powder suspension for Injection

Venetoclax

Intervention Type DRUG

Oral tablet

CCS1477 monotherapy expansion and combination dose finding and expansion - Higher risk MDS

CCS1477 monotherapy, CCS1477 combination with azacitidine

Group Type EXPERIMENTAL

CCS1477

Intervention Type DRUG

Oral capsule

Azacitidine

Intervention Type DRUG

Powder suspension for Injection

Interventions

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CCS1477

Oral capsule

Intervention Type DRUG

Pomalidomide

oral capsule

Intervention Type DRUG

Dexamethasone

oral tablet

Intervention Type DRUG

Azacitidine

Powder suspension for Injection

Intervention Type DRUG

Venetoclax

Oral tablet

Intervention Type DRUG

Bortezomib

Powder for solution for injection

Intervention Type DRUG

Ixazomib

Oral capsule

Intervention Type DRUG

Elranatamab

Solution for injection

Intervention Type DRUG

Teclistamab

Solution for injection

Intervention Type DRUG

Lenalidomide

Oral capsule

Intervention Type DRUG

Daratumumab

Solution for injection, concentrate for solution for infusion

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CellCentric Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tim Somervaille

Role: PRINCIPAL_INVESTIGATOR

The Christie NHS Foundation Trust

Locations

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Emory Winship Cancer Institute

Atlanta, Georgia, United States

Site Status RECRUITING

Community Health Network

Indianapolis, Indiana, United States

Site Status RECRUITING

The Center for Cancer and Blood Disorders (CCBD)

Bethesda, Maryland, United States

Site Status RECRUITING

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Site Status RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

Penn Medicine - Abramson Cancer Center Perelman

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Institute Bergonie

Bordeaux, , France

Site Status COMPLETED

Gustave Roussy

Villejuif, , France

Site Status COMPLETED

Hospital Germans Trias i Pujol/ ICO Badalona

Badalona, , Spain

Site Status RECRUITING

University Hospital Vall D'Hebron

Barcelona, , Spain

Site Status COMPLETED

Hospital Clínic de Barcelona

Barcelona, , Spain

Site Status RECRUITING

ICO L'Hospitalet (Instituto Catalán de Oncología)

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario de La Princesa

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Gregorio Marañón

Madrid, , Spain

Site Status RECRUITING

Hospital Infanta Leonor

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status RECRUITING

CIOCC Hospital Universitario HM Sanchinarro

Madrid, , Spain

Site Status COMPLETED

Universidad de Navarra

Pamplona, , Spain

Site Status RECRUITING

Hospital Universitario y Politécnico La Fe de la Comunidad Valenciana

Valencia, , Spain

Site Status RECRUITING

Karolinska Comprehensive Cancer Center

Stockholm, , Sweden

Site Status COMPLETED

The Royal Marsden

Sutton, Surrey, United Kingdom

Site Status RECRUITING

The Clatterbridge Cancer Centre NHS Foundation Trust,

Bebington, , United Kingdom

Site Status RECRUITING

University Hospitals Bristol

Bristol, , United Kingdom

Site Status RECRUITING

University Hospital of Wales

Cardiff, , United Kingdom

Site Status RECRUITING

Royal Derby Hospital

Derby, , United Kingdom

Site Status RECRUITING

Western General Hospital

Edinburgh, , United Kingdom

Site Status RECRUITING

Gartnavel General Hospital

Glasgow, , United Kingdom

Site Status RECRUITING

Leicester Royal Infirmary

Leicester, , United Kingdom

Site Status RECRUITING

St Bartholomew's Hospital

London, , United Kingdom

Site Status RECRUITING

Sarah Cannon Research Institute UK

London, , United Kingdom

Site Status RECRUITING

NIHR University College London Clinical Research Facility

London, , United Kingdom

Site Status RECRUITING

Imperial College

London, , United Kingdom

Site Status RECRUITING

The Christie Hospital

Manchester, , United Kingdom

Site Status RECRUITING

Newcastle upon Tyne Hospitals

Newcastle upon Tyne, , United Kingdom

Site Status RECRUITING

Nottingham University Hospitals NHS Trust

Nottingham, , United Kingdom

Site Status RECRUITING

Cancer and Haematology Centre

Oxford, , United Kingdom

Site Status RECRUITING

University Hospital of Southampton

Southampton, , United Kingdom

Site Status RECRUITING

Royal Stoke University Hospital

Stoke-on-Trent, , United Kingdom

Site Status RECRUITING

Countries

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United States France Spain Sweden United Kingdom

Central Contacts

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Tomasz Knurowski, PhD

Role: CONTACT

Phone: 07882871299

Email: [email protected]

Karen Clegg, MD, MFPM

Role: CONTACT

Email: [email protected]

Facility Contacts

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Dr Nisha Joseph, MD

Role: primary

Pablo M Bedano, MD

Role: primary

Nejma Louahlia

Role: primary

Ashley Servais

Role: primary

Marnee Strege, RN BSN

Role: primary

Dan Vogl, MD

Role: primary

Albert Oriol-Rocafiguera

Role: primary

Laura Rosiñol Dachs

Role: primary

Anna Sureda Balari

Role: primary

Adrian Alegre Amor

Role: primary

Cristina Encinas Rodriguez

Role: primary

Jose Angel Hernandez- Rivas

Role: primary

María J Blanchard Rodriguez

Role: primary

Joaquin Martinez-Lopez

Role: primary

Paula Rodriguez-Otero

Role: primary

Javier de la Rubia Comos

Role: primary

Charlotte Pawlyn

Role: primary

Gillian Brearton, MD

Role: primary

Sally Moore, MD

Role: primary

Steven Knapper

Role: primary

Firas Al-Kaisi, MD

Role: primary

Victoria Campbell

Role: primary

Jennifer Travers

Role: primary

Harriet Walter

Role: primary

Heather Oakervee

Role: primary

Richard Dillon

Role: primary

Jenny O'Nions

Role: primary

Aristeidis Chaidos

Role: primary

Tim Somervaille

Role: primary

Thomas Creasey

Role: primary

Dean Smith

Role: primary

Sarah Gooding

Role: primary

Andy Davies

Role: primary

Kamaraj Karunanithi

Role: primary

Other Identifiers

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CCS1477-02

Identifier Type: -

Identifier Source: org_study_id