A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 in patients with metastatic castration resistant prostate cancer, metastatic breast cancer, non-small cell lung cancer or advanced solid tumours.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Capsules, oral
Abiraterone acetate 500mg tablets plus prednisone/prednisolone
Enzalutamide 40mg capsules/tablets
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
Incidence of treatment-related adverse events
Treatment-related adverse events and serious adverse events
Time frame: Up to 12 months
Laboratory assessments
Clinical chemistry and haematology assessments
Time frame: Up to 12 months
PSA response
PSA response as defined by Prostate Cancer Clinical Trial Working Group 3 (PCWG-3)
Time frame: Up to 12 months
CTC response
CTC response defined as a change from unfavourable (five or more cells) at baseline to favourable (four or fewer cells) post treatment
Time frame: Up to 12 months
Objective response rate (ORR)
* malignant soft tissue response rate (Response Evaluation Criteria in Solid Tumours \[RECIST\] v1.1) * metastatic bone disease status (PCWG-3 bone scan criteria)
Time frame: Up to 12 months
Radiological progression-free survival (rPFS)
Defined as the time from start of treatment until objective disease progression as defined by RECIST 1.1 or PCWG-3 or death
Time frame: Up to 12 months
AUC of CCS1477
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration of CCS1477
Time frame: Up to 30 days after first dose of CCS1477
Cmax of CCS1477
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300mg tablets
150mg tablets
840mg/14ml concentrate for solution for infusion vials
Institute Bergonie
Bordeaux, France
Hôpital Europeen Georges Pompidou
Paris, France
Institute Gustave Roussy
Villejuif, France
Netherlands Cancer Institute (NKI)
Amsterdam, Netherlands
Hospital Vall d'Hebron, VHIO
Barcelona, Spain
START CIOCC Hospital Universitario HM
Madrid, Spain
Karolinska Institute
Stockholm, Sweden
Belfast City Hospital
Belfast, United Kingdom
...and 9 more locations
Maximum observed plasma concentration (Cmax) of CCS1477
Time frame: Up to 30 days after first dose of CCS1477