EUCTR2018-000285-10-ES进行中（未招募）1 期
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. - Phase I/IIa study to evaluate CCS1477 in advanced tumours v1.0
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent; willing and and able to comply with study protocol procedures
- •3. = 18 years
- •4. ECOG performance status 0-1 with no deterioration over previous 2 weeks and minimum life expectancy of 12 weeks
- •5. Adequate organ functions:
- •AST/ALT =3 x ULN or AST/ALT =5 x ULN
- •Total bilirubin =1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, patients with borderline elevation due to underlying liver involvement may be eligible).
- •Calculated creatinine clearance by Cockcroft-Gault formula =30 ml/min²
- •ANC =1.5 x 109/L
- •Platelets =100 x 109/L
- •Haemoglobin =9g/dL
- •6. For duration of the study and 1 week after the last study administration, sexually active male patients must be willing to use barrier contraception with all sexual partners. Where the sexual partner is a ‘woman of child-bearing potential’ who is not using effective contraception, men must use a condom and another form of contraception during the study and for 3 months after the last dose of study medication.
- •7. Females must agree to use highly effective contraceptive measures, must not be breast feeding and must have a negative serum pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential at screening per one of:
- •Post menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments
- •Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
- •Amenorrhoeic for 12 months and serum FSH, LH and plasma oestradiol levels in the postmenopausal range for institution
- •8. Patients must have assessable disease (by CT, MRI, bone scan or X-ray) but are not required to have measurable disease
- •Additional inclusion criteria for Parts A, B, C & D (mCRPC)
- •9. Patients must have previously received:
- •abiraterone and/or enzalutamide (or equivalent anti-androgen), and
- •a taxane (unless ineligible or refused)
- •10. Progressive disease documented by one or more of:
- •Biochemical progression defined as at least 2 stepwise increases in a series of any 3 PSA values collected while the patient has castrate levels of testosterone. The 3 PSA values selected do not need to be consecutive, and do not need to include the most recent PSA collected at, or prior to, study enrolment, but must meet the following criteria:
- •a. PSA progression defined by minimum of 3 rising PSA levels with an interval of =1 week between each determination
- •b. Each of the 3 PSA values must be collected while the patient is under medical castration or is surgically castrated
- •c. Ideally all 3 should be done after anti-androgen withdrawal (if applicable), but they can be done during the withdrawal period
- •Progression as defined by RECIST v1.1 guideline for assessment of malignant soft tissue disease or modified RECIST v1.1 criteria as defined by PCWG-3 for progression of nodes
- •Progression defined as 2 or more new metastatic bone lesions confirmed on bone scan from a previous assessment
- •11. PSA at screening must be =2 µg/L (2 ng/mL)
- •12. Serum testosterone concentration =50 ng/dL sustained by medical or surgical castration
- •13. Serum albumin >2.5 g/dL
- •Additional Part C inclusion criteria (CCS1477 plus abiraterone)
- •14. Patients must have previously progressed on abiraterone treatment
- •15. Patients whose last dose of abiraterone is >6 months prior to start
排除标准
- •All Patients:
- •1. Intervention with any of the following
- •Any chemotherapy, investigational agents or other anti-cancer drugs within 14 days or 5 half-lives (whichever is longer of these two) of the first dose of study treatment (excludes treatment with immunotherapy agents which must be assessed on a case by case basis). This does not apply to prior treatment with abiraterone for patients in Part C1 or C2 or prior treatment with enzalutamide for patients in Part D1 (except patients in the DDI arm who must have a 4 week washout of enzalutamide prior to starting the study) and D2.
- •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 as judged by the investigator, within 4 weeks of the first dose of study treatment, or have an anticipated need for major surgery during the study
- •Strong inducers of CYP3A4 (See Appendix E) taken within 4 weeks of the first dose of study treatment or while on study treatment (excluding enzalutamide in Part D1 and D2 which does not require a 4 week wash-out prior to the first dose of study treatment, except for patients in the DDI arm).
- •Strong inhibitors of CYP3A4. CYP3A4 substrates with a narrow therapeutic range, CYP2C8 or CYP3A4 sensitive substrates (See Appendix E) taken within 2 weeks of the first dose of study treatment or while on study treatment.
- •Washout periods may be reduced for specific medications (eg. statins) following discussion with the medical monitor.
- •Herbal medications cannot be taken within 7 days of the first dose of study treatment (4 weeks for St John’s wort) or while on study treatment
- •Statins; patients should discontinue statins 5 half-lives prior to starting study treatment
- •2. Any unresolved reversible toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment with the exception of alopecia and neuropathy
- •3. Female patients who are pregnant or breast-feeding at study entry
- •4. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator’s opinion makes it undesirable for the patient to participate in the study or which would jeopardise compliance with the protocol, or active infection* including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). *Active viral infection is defined as requiring antiviral therapy. Screening for chronic conditions is not required
- •5. Patients with any known uncontrolled inter-current illness including ongoing or active clinically significant infections, symptomatic congestive heart failure, hypertension, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •6. Repeatable QTcF prolongation (>480 msec)
- •7. Prior malignancy that could affect compliance with the protocol or interpretation of results. Patients with a history of non-melanoma skin cancers or carcinoma in situ treated with curative intent, are generally eligible
- •8. Primary brain tumours or known or suspected brain metastases. Patients with brain metastases could be eligible if treated and stable within 28 days of the first dose of study treatment (after discussion and agreement with the CellCentric medical advisor).
- •9. Patients with any known severe allergies to any active or i
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