Phase I/IIa study to evaluate CCS1477 in advanced tumours v1.0
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 solid/metastatic tumours.
IRAS ID
242259
Contact name
Johann de Bono
Contact email
Sponsor organisation
CellCentric Ltd
Eudract number
2018-000285-10
Duration of Study in the UK
3 years, 6 months, 31 days
Research summary
CCS1477 is a new experimental medication (sponsored by CellCentric Ltd) for a type of prostate cancer called metastatic castration resistant prostate cancer (mCRPC). It is aimed at tumours that are not responsive to, or have become resistant to, existing medications used in late stage disease. CCS1477 may also be used for other cancers with specific gene mutations, again where existing treatments are no longer working. The purpose of this study is to examine the safety, tolerability, pharmacokinetics (PK) and efficacy of CCS1477 when treating patients with mCRPC, when given alone or in combination with other standard mCRPC therapies, and in treating patients with other solid tumour cancers which have a gene mutation in p300 or CBP.
It is expected that approximately 150 patients will be recruited from up to 20 hospitals in the UK and US. 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 the tumour.
The information gained in this study will help the sponsor to determine whether CCS1477 is suitable for further studies in humans.
REC name
London - Chelsea Research Ethics Committee
REC reference
18/LO/0543
Date of REC Opinion
27 Apr 2018
REC opinion
Further Information Favourable Opinion