- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03568656
Study to Evaluate CCS1477 in Advanced Tumours
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Tomasz Knurowski, MD, MFPM
- Phone Number: 07882 871299
- Email: Tomasz.Knurowski@cellcentric.com
Study Contact Backup
- Name: Karen Clegg, PhD
- Email: Karen.Clegg@cellcentric.com
Study Locations
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Bordeaux, France, 33000
- Completed
- Institute Bergonie
-
Paris, France, 75015
- Completed
- Hopital Europeen Georges Pompidou
-
Villejuif, France, 94805
- Completed
- Institute Gustave Roussy
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Amsterdam, Netherlands, 1066 CX
- Completed
- Netherlands Cancer Institute (NKI)
-
Rotterdam, Netherlands, 3015 GD
- Withdrawn
- Erasmus MC Institute
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Barcelona, Spain, 08035
- Completed
- Hospital Vall d'Hebron, VHIO
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Madrid, Spain, 28050
- Completed
- START CIOCC Hospital Universitario HM
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Valencia, Spain, 46010
- Withdrawn
- INCLIVA Biomedical Research Institute
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Stockholm, Sweden, 171 76
- Completed
- Karolinska Institute
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Belfast, United Kingdom, BT9 7AB
- Recruiting
- Belfast City Hospital
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Contact:
- Victoria Coyle
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Birmingham, United Kingdom, B15 2TH
- Recruiting
- Queen Elizabeth Hospital Cancer Centre
-
Contact:
- Daniel Ford
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Cambridge, United Kingdom, CB2 0QQ
- Recruiting
- Cambridge University Hospital
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Contact:
- Simon Pacey
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Edinburgh, United Kingdom, EH4 2XU
- Recruiting
- Edinburgh Cancer Centre Western General Hospital
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Contact:
- Aravind Sundaramurthy
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Glasgow, United Kingdom, G12 0YN
- Recruiting
- The Beatson West of Scotland Cancer Centre
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Contact:
- Richard Wilson
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Leicester, United Kingdom, LE1 5WW
- Recruiting
- Leicester Royal Infirmary
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Contact:
- Harriet Walter
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Manchester, United Kingdom, M20 4BX
- Recruiting
- The Christie Hospital
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Contact:
- Louise Carter
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Newcastle, United Kingdom, NE7 7DN
- Recruiting
- Freeman Hospital
-
Contact:
- Ruth Plummer
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Southampton, United Kingdom, SO16 6YD
- Recruiting
- University Hospital Southampton
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Contact:
- Simon Crabb
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Sutton, United Kingdom, SM2 5NG
- Recruiting
- Royal Marsden Hospital
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Contact:
- Johann de Bono
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Completed
- Dana-Farber Cancer Institute
-
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New York
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New York, New York, United States, 10065
- Withdrawn
- New York-Presbyterian Hospital/Weill Cornell Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Completed
- Thomas Jefferson University, Sidney Kimmel Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Provision of consent
- ECOG performance status 0-1
- Assessable disease (by CT, MRI, bone scan or X-ray)
- Adequate organ function
- Highly effective contraception measures for duration of study
Additional inclusion criteria for mCRPC patients only:
- Previously received abiraterone and/or enzalutamide (or equivalent anti-androgen), and docetaxel (unless ineligible or refused)
Progressive disease documented by one or more of the following:
- Biochemical progression defined as at least 2 stepwise increases in a series of any 3 PSA values
- Progression as defined by RECIST v1.1 guideline for assessment of malignant soft tissue disease.
- Progression defined as two or more new metastatic bone lesions confirmed on bone scan from a previous assessment
- PSA at screening ≥2 μg/L
- Serum testosterone concentration ≤50 ng/dL
- Serum albumin >2.5 g/dL
Additional inclusion criteria for patients in CCS1477 plus abiraterone combination arm:
- Patients must have previously progressed on abiraterone treatment
- Patients whose last dose of abiraterone is greater than 6 months prior to start of study treatment will receive a 4-week run-in treatment with abiraterone to confirm refractoriness to abiraterone treatment
Additional inclusion criteria for patients in CCS1477 plus enzalutamide combination arm:
- Patients must have previously progressed on enzalutamide treatment
- Patients whose last dose of enzalutamide is greater than 6 months prior to start of study treatment will receive a 4-week run-in treatment with enzalutamide to confirm refractoriness to enzalutamide treatment
Additional inclusion criteria for patients in mutation arm:
- Advanced solid tumour with identification of markers which may indicate potential for response to p300/CBP inhibition. Markers include loss of function mutations in CREBBP, EP300 or ARID1A, MYC gene amplifications or rearrangements and androgen receptor (AR) gene amplifications or over-expression.
Exclusion Criteria:
- Intervention with any chemotherapy, investigational agents or other anti-cancer drugs within 14 days or 5 half-lives of the first dose
- Radiotherapy with a wide field of radiation or to more than 30% of the bone marrow within 4 weeks of the first dose of study treatment
- 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
- Statins; patients should discontinue statins prior to starting study treatment
- Any unresolved reversible toxicities from prior therapy >CTCAE grade 1 at the time of starting study treatment
- Any evidence of severe or uncontrolled systemic diseases
- Any known uncontrolled inter-current illness
- QTcF prolongation (> 480 msec).
- Primary brain tumours or known or suspected brain metastases.
Additional exclusion criteria for patients in CCS1477 plus abiraterone combination arm:
- Clinically significant cardiac abnormalities
Additional exclusion criteria for patients in CCS1477 plus enzalutamide combination arm:
- History of seizures or other predisposing factors
- Use of substrates with a narrow therapeutic index metabolised by CYP2C9 or CYP2C19 within 2 weeks of the first dose of study treatment
- Clinically significant cardiac abnormalities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CCS1477 dose escalation - mCRPC
CCS1477 monotherapy in patients with mCRPC
|
Capsules, oral
|
Experimental: CCS1477 expansion phase - mCRPC
CCS1477 monotherapy in patients with mCRPC
|
Capsules, oral
|
Experimental: CCS1477 and abiraterone acetate, combination dose finding and expansion - mCRPC
CCS1477 plus abiraterone acetate in patients with mCRPC
|
Capsules, oral
Abiraterone acetate 500mg tablets plus prednisone/prednisolone
|
Experimental: CCS1477 and enzalutamide, combination dose finding and expansion - mCRPC
CCS1477 plus enzalutamide in patients with mCRPC
|
Capsules, oral
Enzalutamide 40mg capsules/tablets
|
Experimental: CCS1477 Monotherapy - Solid tumours
CCS1477 expansion phase in patients with advanced solid tumours with molecular markers which may indicate potential for response to p300/CBP inhibition
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Capsules, oral
|
Experimental: CCS1477 and darolutamide, combination dose finding and expansion - mCRPC
CCS1477 plus darolutamide in patients with mCRPC
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Capsules, oral
300mg tablets
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Experimental: CCS1477 and olaparib, combination dose finding and expansion - mCRPC and metastatic breast cancer
CCS1477 plus olaparib in patients with mCRPC or metastatic breast cancer.
|
Capsules, oral
150mg tablets
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Experimental: CCS1477 and atezolizumab, combination dose finding and expansion - non-small cell lung cancer
CCS1477 plus atezolizumab in patients with non-small cell lung cancer
|
Capsules, oral
840mg/14ml concentrate for solution for infusion vials
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of treatment-related adverse events
Time Frame: Up to 12 months
|
Treatment-related adverse events and serious adverse events
|
Up to 12 months
|
Laboratory assessments
Time Frame: Up to 12 months
|
Clinical chemistry and haematology assessments
|
Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PSA response
Time Frame: Up to 12 months
|
PSA response as defined by Prostate Cancer Clinical Trial Working Group 3 (PCWG-3)
|
Up to 12 months
|
CTC response
Time Frame: Up to 12 months
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CTC response defined as a change from unfavourable (five or more cells) at baseline to favourable (four or fewer cells) post treatment
|
Up to 12 months
|
Objective response rate (ORR)
Time Frame: Up to 12 months
|
|
Up to 12 months
|
Radiological progression-free survival (rPFS)
Time Frame: Up to 12 months
|
Defined as the time from start of treatment until objective disease progression as defined by RECIST 1.1 or PCWG-3 or death
|
Up to 12 months
|
AUC of CCS1477
Time Frame: Up to 30 days after first dose of CCS1477
|
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration of CCS1477
|
Up to 30 days after first dose of CCS1477
|
Cmax of CCS1477
Time Frame: Up to 30 days after first dose of CCS1477
|
Maximum observed plasma concentration (Cmax) of CCS1477
|
Up to 30 days after first dose of CCS1477
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Johann de Bono, MD, Royal Marsden NHS Foundation Trust
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Immunological
- Poly(ADP-ribose) Polymerase Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Immune Checkpoint Inhibitors
- Steroid Synthesis Inhibitors
- Olaparib
- Abiraterone Acetate
- Atezolizumab
Other Study ID Numbers
- CCS1477-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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