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Study to Evaluate CCS1477 in Haematological Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068597
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : May 13, 2022
Sponsor:
Information provided by (Responsible Party):
CellCentric Ltd.

Brief Summary:
A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome.

Condition or disease Intervention/treatment Phase
Haematological Malignancy Acute Myeloid Leukemia Non Hodgkin Lymphoma Multiple Myeloma Drug: CCS1477 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: The RP2D/MTD dose will be determined in Parts A and B. Parts C-E will run in parallel after the completion of Parts A and B.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Phase I/IIa Study to Evaluate the Safety and Efficacy of CCS1477 as Monotherapy in Patients With Advanced Haematological Malignancies.
Actual Study Start Date : August 9, 2019
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024


Arm Intervention/treatment
Experimental: CCS1477 dose escalation NHL/MM Drug: CCS1477
Oral

Experimental: CCS1477 dose escalation AML/High risk MDS Drug: CCS1477
Oral

Experimental: CCS1477 expansion phase NHL Drug: CCS1477
Oral

Experimental: CCS1477 expansion phase MM Drug: CCS1477
Oral

Experimental: CCS1477 expansion phase AML/High risk MDS Drug: CCS1477
Oral




Primary Outcome Measures :
  1. Incidence of treatment-related adverse events [ Time Frame: Up to 12 months ]
    Treatment-related adverse events and serious adverse events

  2. Incidence of laboratory abnormalities [ Time Frame: Up to 12 months ]
    Laboratory abnormalities characterised by type, frequency, severity and timing


Secondary Outcome Measures :
  1. Response rate [ Time Frame: Up to 12 months ]

    Defined as number of patients who have a response according to

    • RECIL criteria (NHL)
    • IMWG criteria (Multiple myeloma)
    • ELN recommendations 2017 (AML)

  2. Duration of Response [ Time Frame: Up to 12 months ]
    Defined as the time from start of treatment until disease progression

  3. AUC of CCS1477 [ Time Frame: 35 days ]
    Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration of CCS1477

  4. Cmax of CCS1477 [ Time Frame: 35 days ]
    Maximum observed plasma concentration (Cmax) of CCS1477



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (> 480 msec)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068597


Contacts
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Contact: Tomasz Knurowski, PhD 07882871299 Tomasz.Knurowski@cellcentric.com
Contact: Karen Clegg, MD, MFPM Karen.Clegg@cellcentric.com

Locations
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France
Institute Bergonie Recruiting
Bordeaux, France, 33000
Contact: Fontanet Bijou         
Institute Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Vincent Ribrag         
Spain
University Hospital Vall D'Hebron Recruiting
Barcelona, Spain, 08035
Contact: David Valcárcel Ferreiras         
CIOCC Hospital Universitario HM Sanchinarro Recruiting
Madrid, Spain, 28050
Contact: Jaime Perez de Oteyza         
Sweden
Karolinska Institute Recruiting
Stockholm, Sweden, 171 76
Contact: Maria Creignou         
United Kingdom
The Royal Marsden Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Dima El-Sharkawi         
University Hospital of Wales Recruiting
Cardiff, United Kingdom
Contact: Steven Knapper         
Western General Hospital Recruiting
Edinburgh, United Kingdom, EH4 2XU
Contact: Victoria Campbell         
Gartnavel General Hospital Recruiting
Glasgow, United Kingdom, G12 0YN
Contact: Mhairi Copland         
Leicester Royal Infirmary Recruiting
Leicester, United Kingdom
Contact: Harriet Walter         
NIHR University College London Clinical Research Facility Recruiting
London, United Kingdom, W1T 7HA
Contact: Jenny O'Nions         
The Christie Hospital Recruiting
Manchester, United Kingdom
Contact: Tim Somervaille         
Cancer and Haematology Centre Recruiting
Oxford, United Kingdom
Contact: Paresh Vyas         
University Hospital of Southampton Recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Andy Davies         
Sponsors and Collaborators
CellCentric Ltd.
Investigators
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Principal Investigator: Tim Somervaille The Christie NHS Foundation Trust
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Responsible Party: CellCentric Ltd.
ClinicalTrials.gov Identifier: NCT04068597    
Other Study ID Numbers: CCS1477-02
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: May 13, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms
Hematologic Neoplasms
Neoplasms by Histologic Type
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site