Study to Evaluate CCS1477 in Advanced Tumours

Completed · Phase 1/Phase 2

Conditions studied: Metastatic Castration-Resistant Prostate Cancer, Metastatic Breast Cancer, Non-small Cell Lung Cancer, Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT03568656

Run by

CellCentric Ltd.

People needed

220

Starts

2018-07-23

Expected to finish

2025-07-06

Last updated by the study team

2025-08-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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