NCT03398720Unknown1 期
A Two-Part, Phase 1, Open-Label, Multicenter, Non-Randomized, Dose Escalation/Expansion Study to Evaluate the Safety and Tolerability of HTI-1066 in Subjects With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Adverse events
研究概览
简要总结
HTI-1066 is a novel ADC being developed for the treatment of cancers in patients with overexpression of c-Met. This 2-part, Phase 1 study evaluates the safety the tolerability of HTI-1066 in subjects with advanced solid tumors.
详细描述
This is a 2-part dose escalation and dose expansion study. Dose escalation uses a modified "3+3" design and continues until a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identified. In part 2, subjects with selected tumor types will be enrolled at the MTD or RP2D.
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
- •Male or female ≥18 years of age
- •Subject must have an advanced solid tumor
- •ECOG Performance Status of 0 or 1
- •Life expectancy ≥12 weeks
- •Adequate laboratory parameters
- •Female subjects agree not to be pregnant or lactating from beginning of the study screening until 4 months after receiving the last treatment; Male and female subjects and their sexual partners are willing and able to employ a highly effective method of birth control/contraception.
- •Willing and able to comply with clinic visits and study-related procedures
- •Provide signed informed consent
排除标准
- •Hypersensitivity to HTI-1066 or sensitivity to humanized monoclonal antibody products
- •Any concurrent therapy for cancer, radiation, or surgery within 4 weeks, except for minor palliative intent (this is to be discussed with sponsor)
- •Any concurrent use of anti-infective, anti-fungal, or anti-viral agent (exceptions are to be approved by the sponsor)
- •Any other prohibited or restricted medication as described in the study protocol.
- •Investigational therapy administered <5 half-lives before the first dose of HTI-1066
- •Any anticancer therapy administered <5 half-lives before first dose of HTI-1066; any prior immune-oncology products administered within 4 weeks or 5 half-lives before the first dose of HTI-1066 as described above; or surgery or radiotherapy administered within 4 weeks before the first dose of HTI-
- •Active CNS metastases.
- •Cardiac disease (NYHA classes II-IV) including myocardial infarction within 6 months before enrollment, or unstable angina, congestive heart failure, or cardiac arrhythmia requiring treatment.
- •History or presence of an abnormal ECG, ECHO, or MUGA that is clinically meaningful.
- •History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy (e.g., hepatitis B or C)
- •Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare or ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
- •Active infection or an unexplained fever >38.5°C during Screening or on the first scheduled day of dosing.
- •Unresolved toxicities from previous anticancer therapy.
研究组 & 干预措施
Cohort 1
Experimental
One participant will receive HTI-1066 at the starting dose.
干预措施: HTI-1066 dose level 1 (Drug)
Cohort 2
Experimental
Participants will receive HTI-1066 at dose level 2.
干预措施: HTI-1066 dose level 2 (Drug)
Cohort 3
Experimental
Participants will receive HTI-1066 at dose level 3.
干预措施: HTI-1066 dose level 3 (Drug)
Cohort 4
Experimental
Participants will receive HTI-1066 at dose level 4.
干预措施: HTI-1066 dose level 4 (Drug)
结局指标
主要结局
Adverse events
时间窗: Up to 2 year
Number of participants with AEs and SAEs
Dose-limiting toxicity (DLT)
时间窗: Up to 2 years
Number of participants with DLTs
次要结局
- AUC(Up to 1 year)
- Cmax(Up to 1 year)
- Anti-drug antibodies(Up to 2 year)
- Objective response rate(Up to 2 years)
- Progression-free survival (PFS)(Up to 2 years)
研究者
研究点 (3)
Loading locations...
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