An Open-label Phase I/IIa Study to Evaluate the Safety and Efficacy of CCS1477 as Monotherapy and in Combination in Patients With Advanced Haematological Malignancies.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 71
- 主要终点
- Incidence of treatment-related adverse events
研究概览
简要总结
A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 (inobrodib) in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome.
详细描述
This includes patients with Peripheral T-cell lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of consent
- •ECOG performance status 0-2
- •Patients with confirmed (per standard disease specific diagnostic criteria), relapsed or refractory haematological malignancies (NHL, MM and AML)
- •Must have previously received standard therapy
- •Adequate organ function
排除标准
- •Intervention with any chemotherapy, investigational agents or other anti-cancer drugs within 14 days or 5 half-lives of the first dose
- •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
- •Patients should discontinue statins prior to starting study treatment
- •CYP2C8 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment
- •Any unresolved reversible toxicities from prior therapy >CTCAE grade 1 at the time of starting study treatment (except alopecia and grade 2 neuropathy)
- •Any evidence of severe or uncontrolled systemic diseases
- •Any known uncontrolled inter-current illness
- •QTcF prolongation (> 470 msec)
研究组 & 干预措施
CCS1477 dose escalation NHL/MM
CCS1477 monotherapy
干预措施: CCS1477 (Drug)
CCS1477 dose escalation AML/Higher risk MDS
CCS1477 monotherapy
干预措施: CCS1477 (Drug)
CCS1477 monotherapy expansion and combination dose finding and expansion NHL
CCS1477 monotherapy, CCS1477 combination with lenalidomide
干预措施: CCS1477 (Drug)
CCS1477 monotherapy expansion and combination dose finding and expansion NHL
CCS1477 monotherapy, CCS1477 combination with lenalidomide
干预措施: Lenalidomide (Drug)
CCS1477 monotherapy expansion and combination dose finding and expansion - MM
CCS1477 monotherapy, CCS1477 combination with pomalidomide-dexamethasone, CCS1477 combination with bortezomib-dexamethasone, CCS1477 combination with ixazomib-dexamethasone, CCS1477 combination with elranatamab, CCS1477 combination with teclistamab, CCS1477 combination with lenalidomide, CCS1477 combination with lenalidomide and daratumumab
干预措施: CCS1477 (Drug)
CCS1477 monotherapy expansion and combination dose finding and expansion - MM
CCS1477 monotherapy, CCS1477 combination with pomalidomide-dexamethasone, CCS1477 combination with bortezomib-dexamethasone, CCS1477 combination with ixazomib-dexamethasone, CCS1477 combination with elranatamab, CCS1477 combination with teclistamab, CCS1477 combination with lenalidomide, CCS1477 combination with lenalidomide and daratumumab
干预措施: Pomalidomide (Drug)
CCS1477 monotherapy expansion and combination dose finding and expansion - MM
CCS1477 monotherapy, CCS1477 combination with pomalidomide-dexamethasone, CCS1477 combination with bortezomib-dexamethasone, CCS1477 combination with ixazomib-dexamethasone, CCS1477 combination with elranatamab, CCS1477 combination with teclistamab, CCS1477 combination with lenalidomide, CCS1477 combination with lenalidomide and daratumumab
干预措施: Dexamethasone (Drug)
CCS1477 monotherapy expansion and combination dose finding and expansion - MM
CCS1477 monotherapy, CCS1477 combination with pomalidomide-dexamethasone, CCS1477 combination with bortezomib-dexamethasone, CCS1477 combination with ixazomib-dexamethasone, CCS1477 combination with elranatamab, CCS1477 combination with teclistamab, CCS1477 combination with lenalidomide, CCS1477 combination with lenalidomide and daratumumab
干预措施: Bortezomib (Drug)
CCS1477 monotherapy expansion and combination dose finding and expansion - MM
CCS1477 monotherapy, CCS1477 combination with pomalidomide-dexamethasone, CCS1477 combination with bortezomib-dexamethasone, CCS1477 combination with ixazomib-dexamethasone, CCS1477 combination with elranatamab, CCS1477 combination with teclistamab, CCS1477 combination with lenalidomide, CCS1477 combination with lenalidomide and daratumumab
干预措施: Ixazomib (Drug)
CCS1477 monotherapy expansion and combination dose finding and expansion - MM
CCS1477 monotherapy, CCS1477 combination with pomalidomide-dexamethasone, CCS1477 combination with bortezomib-dexamethasone, CCS1477 combination with ixazomib-dexamethasone, CCS1477 combination with elranatamab, CCS1477 combination with teclistamab, CCS1477 combination with lenalidomide, CCS1477 combination with lenalidomide and daratumumab
干预措施: Elranatamab (Drug)
CCS1477 monotherapy expansion and combination dose finding and expansion - MM
CCS1477 monotherapy, CCS1477 combination with pomalidomide-dexamethasone, CCS1477 combination with bortezomib-dexamethasone, CCS1477 combination with ixazomib-dexamethasone, CCS1477 combination with elranatamab, CCS1477 combination with teclistamab, CCS1477 combination with lenalidomide, CCS1477 combination with lenalidomide and daratumumab
干预措施: Teclistamab (Drug)
CCS1477 monotherapy expansion and combination dose finding and expansion - MM
CCS1477 monotherapy, CCS1477 combination with pomalidomide-dexamethasone, CCS1477 combination with bortezomib-dexamethasone, CCS1477 combination with ixazomib-dexamethasone, CCS1477 combination with elranatamab, CCS1477 combination with teclistamab, CCS1477 combination with lenalidomide, CCS1477 combination with lenalidomide and daratumumab
干预措施: Lenalidomide (Drug)
CCS1477 monotherapy expansion and combination dose finding and expansion - MM
CCS1477 monotherapy, CCS1477 combination with pomalidomide-dexamethasone, CCS1477 combination with bortezomib-dexamethasone, CCS1477 combination with ixazomib-dexamethasone, CCS1477 combination with elranatamab, CCS1477 combination with teclistamab, CCS1477 combination with lenalidomide, CCS1477 combination with lenalidomide and daratumumab
干预措施: Daratumumab (Drug)
CCS1477 monotherapy expansion and combination dose finding and expansion - AML
CCS1477 monotherapy, CCS1477 combination with azacitidine, CCS1477 combination with azacitidine and venetoclax
干预措施: CCS1477 (Drug)
CCS1477 monotherapy expansion and combination dose finding and expansion - AML
CCS1477 monotherapy, CCS1477 combination with azacitidine, CCS1477 combination with azacitidine and venetoclax
干预措施: Azacitidine (Drug)
CCS1477 monotherapy expansion and combination dose finding and expansion - AML
CCS1477 monotherapy, CCS1477 combination with azacitidine, CCS1477 combination with azacitidine and venetoclax
干预措施: Venetoclax (Drug)
CCS1477 monotherapy expansion and combination dose finding and expansion - Higher risk MDS
CCS1477 monotherapy, CCS1477 combination with azacitidine
干预措施: CCS1477 (Drug)
CCS1477 monotherapy expansion and combination dose finding and expansion - Higher risk MDS
CCS1477 monotherapy, CCS1477 combination with azacitidine
干预措施: Azacitidine (Drug)
结局指标
主要结局
Incidence of treatment-related adverse events
时间窗: Up to 12 months
Treatment-related adverse events and serious adverse events
Incidence of laboratory abnormalities
时间窗: Up to 12 months
Laboratory abnormalities characterised by type, frequency, severity and timing
次要结局
- Duration of Response(Up to 12 months)
- Response rate(Up to 12 months)
- AUC of CCS1477(35 days)
- Cmax of CCS1477(35 days)