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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

Not Enrolling

Trial ID:NCT03568656

View complete trial on ClinicalTrials.gov

Protocol #:21-430

877-DF-TRIAL (877-338-7425)

Condition(s):Advanced Solid Tumors, Metastatic Breast Cancer, Metastatic Castration-Resistant Prostate Cancer, Non-small Cell Lung Cancer

Phase:I/II

Principal Investigator:Tewari, Alok

Site Research Nurse(s):Leisner, Claire,
Prisby, Judith,

Trial Description:
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.

Eligibility Requirements:
- 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

Protocol #: 21-430

Questions & Enrollment
877-DF-TRIAL
(877-338-7425)