Study to Evaluate CCS1477 in Haematological Malignancies

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04068597
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

CellCentric Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Tim Somervaille
Principal Investigator Affiliation The Christie NHS Foundation Trust
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries France, Spain, Sweden, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

This includes patients with Peripheral T-cell lymphoma.

Arms & Interventions

Arms

Experimental: CCS1477 dose escalation NHL/MM

CCS1477 monotherapy

Experimental: CCS1477 dose escalation AML/Higher risk MDS

CCS1477 monotherapy

Experimental: CCS1477 expansion phase NHL/Peripheral T-cell lymphoma

CCS1477 monotherapy

Experimental: CCS1477 monotherapy expansion and combination dose finding and expansion - MM

CCS1477 monotherapy, CCS1477 combination with pomalidomide-dexamethasone

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, CCS1477 combination with azacitidine and venetoclax

Interventions

Drug: - CCS1477

Oral capsule

Drug: - Pomalidomide

oral capsule

Drug: - Dexamethasone

oral tablet

Drug: - Azacitidine

Powder suspension for Injection

Drug: - Venetoclax

Oral tablet

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic, Phoenix, Arizona

Status

Withdrawn

Address

Mayo Clinic

Phoenix, Arizona, 85054

International Sites

Institute Bergonie, Bordeaux, France

Status

Withdrawn

Address

Institute Bergonie

Bordeaux, , 33000

Institute Gustave Roussy, Villejuif, France

Status

Completed

Address

Institute Gustave Roussy

Villejuif, , 94805

University Hospital Vall D'Hebron, Barcelona, Spain

Status

Completed

Address

University Hospital Vall D'Hebron

Barcelona, , 08035

Madrid, Spain

Status

Completed

Address

CIOCC Hospital Universitario HM Sanchinarro

Madrid, , 28050

Karolinska Institute, Stockholm, Sweden

Status

Completed

Address

Karolinska Institute

Stockholm, , 171 76

The Royal Marsden, Sutton, Surrey, United Kingdom

Status

Recruiting

Address

The Royal Marsden

Sutton, Surrey, SM2 5PT

Site Contact

Dima El-Sharkawi

Tomasz.Knurowski@cellcentric.com

07882871299

University Hospital of Wales, Cardiff, United Kingdom

Status

Recruiting

Address

University Hospital of Wales

Cardiff, ,

Site Contact

Steven Knapper

Tomasz.Knurowski@cellcentric.com

07882871299

Western General Hospital, Edinburgh, United Kingdom

Status

Recruiting

Address

Western General Hospital

Edinburgh, , EH4 2XU

Site Contact

Victoria Campbell

Tomasz.Knurowski@cellcentric.com

07882871299

Gartnavel General Hospital, Glasgow, United Kingdom

Status

Recruiting

Address

Gartnavel General Hospital

Glasgow, , G12 0YN

Site Contact

Mhairi Copland

Tomasz.Knurowski@cellcentric.com

07882871299

Leicester Royal Infirmary, Leicester, United Kingdom

Status

Recruiting

Address

Leicester Royal Infirmary

Leicester, ,

Site Contact

Harriet Walter

Tomasz.Knurowski@cellcentric.com

07882871299

London, United Kingdom

Status

Recruiting

Address

NIHR University College London Clinical Research Facility

London, , W1T 7HA

Site Contact

Jenny O'Nions

Tomasz.Knurowski@cellcentric.com

07882871299

The Christie Hospital, Manchester, United Kingdom

Status

Recruiting

Address

The Christie Hospital

Manchester, ,

Site Contact

Tim Somervaille

Tomasz.Knurowski@cellcentric.com

07882871299

Cancer and Haematology Centre, Oxford, United Kingdom

Status

Recruiting

Address

Cancer and Haematology Centre

Oxford, ,

University Hospital of Southampton, Southampton, United Kingdom

Status

Recruiting

Address

University Hospital of Southampton

Southampton, , SO16 6YD