NCT04145622招募中1 期
Phase I/II, Two-Part, Multicenter First-in-Human Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Subjects With Advanced Solid Malignant Tumors (IDeate-PanTumor01)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 50
- 主要终点
- Evaluate the incidence of adverse events (AEs)
研究概览
简要总结
This is a single group study of participants with advanced solid tumors who have not been cured by other treatments. It is the first time the drug will be used in humans, and will be in two parts.
The primary purpose of the parts are:
- Dose Escalation Part: To evaluate the safety and tolerability and to determine the maximum tolerated dose and the recommended dose for expansion of ifinatamab deruxtecan (I-DXd).
- Dose Expansion Part: To investigate the safety, tolerability and antitumor activity of I-DXd when administered as a single agent.
This study is expected to last approximately 5 years from the time the first participant is enrolled to the time the last participant is off the study.
The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless:
- they withdraw
- their disease gets worse
- they experience unacceptable side effects.
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
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or
- •Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by Investigator. Measurable lesions should not be from a previously irradiated site. If the lesion at a previously irradiated site is the only selectable target lesion, a radiological assessment showing significant progression of the irradiated lesion should be provided by the Investigator
- •Has adequate cardiac, hematopoietic, renal and hepatic functions
- •Has an adequate treatment washout period prior to start of study treatment
- •Has a pathologically documented advanced/unresectable or metastatic head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, squamous and adenocarcinoma non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), bladder cancer, sarcoma, endometrial cancer, melanoma, adenocarcinoma CRPC (primary neuroendocrine or histologically confirmed neuroendocrine differentiated prostate cancer is not allowed), breast cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- •For Expansion Cohort 4 2L ESCC participants only:
- •Has disease progression a post platinum-based and an immune checkpoint inhibitor (ICI) treatment per global or local guidelines, with a maximum of one prior line of systemic therapy for unresectable advanced or metastatic ESCC.
排除标准
- •Has prior treatment with B7-H3 targeted agent, including I-DXd.
- •Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (e.g., trastuzumab deruxtecan) due to treatment-related toxicities.
- •Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial GI tract tumors and non-muscle invasive bladder cancer curatively resected by endoscopic surgery.
- •Uncontrolled significant cardiovascular disease
- •Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement, prior pneumonectomy, or requirement for supplemental oxygen
- •Has an uncontrolled infection requiring systemic therapy.
- •Has substance abuse or any other medical conditions that would increase the safety risk to the subject or interfere with participation of the subject or evaluation of the clinical study in the opinion of the Investigator.
研究组 & 干预措施
Dose escalation
Experimental
Participants with advanced solid tumors who received I-DXd IV Q3W monotherapy during dose escalation phase. Enrollment to this phase is currently closed.
干预措施: Ifinatamab deruxtecan (I-DXd) (Drug)
Dose expansion
Experimental
Currently enrolling participants with advanced solid tumors who will receive I-DXd IV Q3W monotherapy at the recommended dose for expansion.
干预措施: Ifinatamab deruxtecan (I-DXd) (Drug)
结局指标
主要结局
Evaluate the incidence of adverse events (AEs)
时间窗: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Evaluate the incidence of dose-limiting toxicities (DLTs)
时间窗: Day 1 to Day 21 in Cycle 1 in the dose escalation part
Investigate the antitumor activity of ifinatamab deruxtecan (I-DXd)
时间窗: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
次要结局
- Characterize the PK parameter Tmax(Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days))
- Characterize the PK parameter Ctrough(Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days))
- Characterize the PK parameter Cmax(Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days))
- Characterize the PK parameter AUClast(Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days))
- Characterize the PK parameter AUCtau(Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days))
- Assess the incidence of anti-drug antibodies (ADAs)(Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days))
研究者
研究点 (50)
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