NCT04441099终止1 期
A First-in-Human, Phase 1/2 Study of NBE-002, an Anti-ROR1 Antibody Drug Conjugate, in Patients With Advanced Solid Tumors
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
- 12
- 试验地点
- 3
- 主要终点
- Anti-tumor Activity (Phase 2)
研究概览
简要总结
This first-in-human study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of NBE-002, a novel anti-ROR1 antibody-drug conjugate, in patients with advanced solid tumors.
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
- •Written informed consent
- •Age ≥18 years
- •Phase 1, DEC and SEC: patients with histologically or cytologically confirmed advanced solid tumor (carcinoma or sarcoma), who have progressive disease, have undergone systemic therapy for advanced disease, and for whom no standard therapy is available
- •Phase 2, EC1: patients with histologically or cytologically confirmed advanced triple-negative breast cancer, who have progressive disease, and have undergone no more than three prior lines of systemic therapy for advanced disease
- •Phase 2, EC2: patients with histologically or cytologically confirmed advanced solid tumor (carcinoma or sarcoma) other than TNBC, who have progressive disease, and have undergone no more than three prior lines of systemic therapy for advanced disease
- •Availability of pretreatment tumor tissue
- •Phase 1, DEC and SEC: at least one measurable or non-measurable lesion as per RECIST v1.1
- •Phase 2, EC1 and EC2: at least one measurable lesion as per RECIST v1.1
- •Phase 1, DEC and SEC: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- •Phase 2, EC1 and EC2: ECOG performance status of 0 or 1
- •Adequate function of bone marrow, liver, kidneys, heart; adequate coagulation profile
- •Both male and female patients must agree to use effective contraceptive methods
- •Women of child-bearing potential (WCBP) must have a negative serum pregnancy test
- •Patients must be willing and able to sign the informed consent form, and to adhere to the study visit schedule and other protocol requirements
排除标准
- •Prior treatment with any agent targeting ROR1
- •Presence of active central nervous system (CNS) metastasis
- •Persistent toxicities from previous systemic anti-neoplastic treatments of Grade > 1 (or Grade > 2 for neurotoxicity)
- •Systemic anti-neoplastic therapy within five half-lives or four weeks (six weeks for nitrosourea and mitomycin-C), whichever is shorter, prior to first dose of the study drug
- •Wide-field radiotherapy within four weeks, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within two weeks prior to first dose of the study drug, or no recovery from side effects of such intervention
- •Major surgery within four weeks prior to first dose of the study drug, or no recovery from side effects of such intervention
- •Prior allogeneic bone marrow transplantation
- •Significant cardiac disease
- •History of thromboembolic or cerebrovascular events within six months prior to first dose of the study drug
- •Acute and/or clinically significant bacterial, fungal or viral infection
- •Concomitant use of systemic steroids at dose of >10 mg of prednisone or its equivalent per day
- •Concurrent participation in another investigational clinical trial
- •Pregnant or breast-feeding females
- •Other conditions that prevent the patient from giving informed consent or participating in the trial, or that may increase the risk associated with the study participation, or that may interfere with the interpretation of the study results
- •Prior history of malignancy other than inclusion diagnosis within three years prior to first dose of the study drug
- •Prior treatment with cumulative lifetime dose of anthracycline
研究组 & 干预措施
Dose-escalation Cohort (DEC)
Experimental
Escalating doses of NBE-002 depending on cohort at enrollment.
干预措施: NBE-002 (Drug)
Safety-expansion Cohort (SEC)
Experimental
Dose to be determined based on DEC.
干预措施: NBE-002 (Drug)
Expansion Cohort 1 (EC1)
Experimental
Dose to be determined based on DEC and SEC.
干预措施: NBE-002 (Drug)
Expansion Cohort 2 (EC2)
Experimental
Dose to be determined based on DEC and SEC.
干预措施: NBE-002 (Drug)
结局指标
主要结局
Anti-tumor Activity (Phase 2)
时间窗: Up to 60 months
Anti-tumor activity will be assessed by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
Recommended Phase 2 Dose (RP2D) (Phase 1)
时间窗: Up to 48 months
The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data
次要结局
- Concentrations of NBE-002(Up to 60 months)
- Preliminary Anti-tumor Activity (Phase 1)(Up to 48 months)
- Incidence of Adverse Events (Safety and Tolerability)(Up to 60 months)
- Concentrations of NBE-002-reactive antibodies(Up to 60 months)
研究者
研究点 (3)
Loading locations...
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