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.
Research type
Research Study
Full title
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.
IRAS ID
259880
Contact name
Tim Somervaille
Contact email
Sponsor organisation
CellCentric Ltd
Eudract number
2019-000104-15
Duration of Study in the UK
3 years, 4 months, days
Research summary
CCS1477 is a new experimental medication (sponsored by CellCentric Ltd) for a group of cancers that effect the blood and/or bone marrow. These include Acute Myeloid Leukaemia (AML), high-risk Myelodysplastic Syndrome (MDS), Multiple Myeloma (MM) and Non-Hodgkin Lymphoma (NHL). It is aimed at tumours that are not responsive to, or have become resistant to, existing medications used in late stage disease.
The purpose of this study is to examine the safety, tolerability, pharmacokinetics (PK) and efficacy of CCS1477 when treating patients with the above disorders. It is expected that approximately 90 patients will be recruited from up to 10 hospitals in the UK. The study has 5 parts consisting of dose escalation and expansion cohorts. Patients will have regular clinic visits for various safety and clinical benefit assessments, to monitor any side effects and to find out how CCS1477 is handled by the body and affects this group of cancers.
The information gained in this study will help the sponsor to determine whether CCS1477 is suitable for further studies in humans.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
19/SC/0221
Date of REC Opinion
22 May 2019
REC opinion
Favourable Opinion