NCT02947152终止1 期
A Phase I, Multicenter, Open-label Dose Escalation and Expansion Study of HKT288, Administered Intravenously in Adult Patients With Advanced Solid Tumors, Including Epithelial Ovarian Cancer and Renal Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Incidence of dose limiting toxicities (DLTs) in the DLT evaluation period
研究概览
简要总结
A first-in-human study using HKT288 in solid tumors, including epithelial ovarian cancer and renal cell carcinoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Advanced (metastatic or locally advanced) serous epithelial ovarian, serous fallopian tubal or serous primary peritoneal cancer or advanced clear cell or papillary renal cell carcinoma who have received or are intolerant to all therapy known to confer clinical benefit for their disease, as determined by the investigator.
- •Tumor sample is available for retrospective CDH6 expression testing
- •Eastern Cooperative Oncology Group (ECOG) Performance status ≤2
排除标准
- •Patient has central nervous system metastatic involvement. Patients with previously treated CNS metastases are also excluded.
- •Patient with any active or chronic corneal disorders
- •Patients with monocular vision or have media opacities or any other condition that precludes monitoring of the retina or fundus.
- •Patients with a history of serious allergic reactions
- •Patients with QTcF >470 msec at screening ECG or congenital long QT syndrome
- •Any prior history of treatment with maytansine (DM1 or DM4)-based ADC
- •Patient have received anti-cancer therapies within the following time frames prior to the first dose of study treatment:
- •Conventional cytotoxic chemotherapy: ≤4 weeks (≤ 6 weeks for nitrosoureas and mitomycin-C)
- •Biologic therapy (e.g., antibodies): ≤4 weeks
- •Non-cytotoxic small molecule therapeutics: ≤5 half-lives or ≤2 weeks (whichever is longer)
- •Other investigational agents: ≤4 weeks
- •Radiation therapy (except for localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture): ≤4 weeks
- •Radiation therapy (localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture) ≤2 weeks
- •Major surgery: ≤2 weeks
研究组 & 干预措施
Dose escalation part
Experimental
Includes patients with serous epithelial ovarian cancer (inclusive of fallopian tubal and peritoneal cancer) and clear cell or papillary renal cell carcinoma
干预措施: HKT288 (Drug)
Dose expansion part (RCC arm)
Experimental
Includes patients with clear cell or papillary renal cell carcinoma
干预措施: HKT288 (Drug)
Dose expansion part (ovarian cancer arm)
Experimental
Includes patients with serous epithelial ovarian cancer (inclusive of fallopian tubal and peritoneal cancer)
干预措施: HKT288 (Drug)
结局指标
主要结局
Incidence of dose limiting toxicities (DLTs) in the DLT evaluation period
时间窗: evaluation period is 21 days
Tolerability as assessed by numbers of dose changes or interruptions
时间窗: Until last dose of study treatment (=average of approximately 6 months after first dose)
Safety assessed by severity of adverse events (AEs) and serious adverse events (SAEs)
时间窗: Until 105 days after last dose of study treatment (=average of approximately 6 months after first dose)
Safety assessed by overall incidence of adverse events (AEs) and serious adverse events (SAEs)
时间窗: Until 105 days after last dose of study treatment (=average of approximately 6 months after first dose)
次要结局
- Presence of anti-HKT288 antibodies.(On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose))
- Pharmacokinetics (PK) parameter (AUC) for HKT288(On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose))
- PK parameters (half-life) for HKT288(On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose))
- Concentration vs. time profiles of total antibody (tAb)(On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose). 1 cycle is 21 days, increases to 28 days if there is a dose delay of 7 days for the start of next dose)
- Objective response rate(every 2 cycles up to Cycle 17 and every 3 cycles thereafter until study treatment discontinuation (=average of approximately 6 months after first dose). Then every 9 weeks until end of disease progression follow-up (up to 12 months))
- Progression-free survival(every 2 cycles up to Cycle 17 and every 3 cycles thereafter until study treatment discontinuation (=average of approximately 6 months after first dose). Then every 9 weeks until end of disease progression follow-up (up to 12 months))
- Disease Control Rate(At 6 months on treatment)
- Duration of response(every 2 cycles up to Cycle 17 and every 3 cycles thereafter until study treatment discontinuation (=average of approximately 6 months after first dose). Then every 9 weeks until end of disease progression follow-up (up to 12 months))
- Best overall response(every 2 cycles up to Cycle 17 and every 3 cycles thereafter until study treatment discontinuation (=average of approximately 6 months after first dose). Then every 9 weeks until end of disease progression follow-up (up to 12 months))
- CDH6 expression level(3 months)
- PK parameter (Cmax) for HKT288(On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose))
- PK parameter (Tmax) for HKT288(On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose))
研究者
研究点 (1)
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