Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
220 participants
INTERVENTIONAL
2018-07-23
2025-07-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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CCS1477 dose escalation - mCRPC
CCS1477 monotherapy in patients with mCRPC
CCS1477
Capsules, oral
CCS1477 expansion phase - mCRPC
CCS1477 monotherapy in patients with mCRPC
CCS1477
Capsules, oral
CCS1477 and abiraterone acetate, combination dose finding and expansion - mCRPC
CCS1477 plus abiraterone acetate in patients with mCRPC
CCS1477
Capsules, oral
Abiraterone acetate
Abiraterone acetate 500mg tablets plus prednisone/prednisolone
CCS1477 and enzalutamide, combination dose finding and expansion - mCRPC
CCS1477 plus enzalutamide in patients with mCRPC
CCS1477
Capsules, oral
Enzalutamide
Enzalutamide 40mg capsules/tablets
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
CCS1477
Capsules, oral
CCS1477 and darolutamide, combination dose finding and expansion - mCRPC
CCS1477 plus darolutamide in patients with mCRPC
CCS1477
Capsules, oral
Darolutamide
300mg tablets
CCS1477 and olaparib, combination dose finding and expansion - mCRPC and metastatic breast cancer
CCS1477 plus olaparib in patients with mCRPC or metastatic breast cancer.
CCS1477
Capsules, oral
Olaparib
150mg tablets
CCS1477 and atezolizumab, combination dose finding and expansion - non-small cell lung cancer
CCS1477 plus atezolizumab in patients with non-small cell lung cancer
CCS1477
Capsules, oral
Atezolizumab
840mg/14ml concentrate for solution for infusion vials
Interventions
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CCS1477
Capsules, oral
Abiraterone acetate
Abiraterone acetate 500mg tablets plus prednisone/prednisolone
Enzalutamide
Enzalutamide 40mg capsules/tablets
Darolutamide
300mg tablets
Olaparib
150mg tablets
Atezolizumab
840mg/14ml concentrate for solution for infusion vials
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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
* 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
* 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.
* Clinically significant cardiac abnormalities
* 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
18 Years
ALL
No
Sponsors
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CellCentric Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Johann de Bono, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Marsden NHS Foundation Trust
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
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
Queen Elizabeth Hospital Cancer Centre
Birmingham, , United Kingdom
Cambridge University Hospital
Cambridge, , United Kingdom
Edinburgh Cancer Centre Western General Hospital
Edinburgh, , United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
The Christie Hospital
Manchester, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
University Hospital Southampton
Southampton, , United Kingdom
Royal Marsden Hospital
Sutton, , United Kingdom
Countries
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References
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Caligiuri M, Williams GL, Castro J, Battalagine L, Wilker E, Yao L, Schiller S, Toms A, Li P, Pardo E, Graves B, Azofeifa J, Chicas A, Herbertz T, Lai M, Basken J, Wood KW, Xu Q, Guichard SM. FT-6876, a Potent and Selective Inhibitor of CBP/p300, is Active in Preclinical Models of Androgen Receptor-Positive Breast Cancer. Target Oncol. 2023 Mar;18(2):269-285. doi: 10.1007/s11523-023-00949-7. Epub 2023 Feb 24.
Eickhoff N, Bergman AM, Zwart W. Homing in on a Moving Target: Androgen Receptor Cistromic Plasticity in Prostate Cancer. Endocrinology. 2022 Oct 11;163(11):bqac153. doi: 10.1210/endocr/bqac153.
Other Identifiers
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CCS1477-01
Identifier Type: -
Identifier Source: org_study_id
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