NCT05394675进行中（未招募）1 期
A Phase 1, First-in-Human Study of DS-9606a in Patients With Tumor Types Known to Express Claudin-6 (CLDN6)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 88
- 试验地点
- 7
- 主要终点
- Number of Participants with Dose-Limiting Toxicities (DLT) in Participants Receiving DS-9606a
研究概览
简要总结
This study will assess the safety and tolerability of DS-9606a in patients with advanced solid tumors.
详细描述
This is a first-in-human, phase 1, dose escalation study of the anti-CLDN6 ADC, DS-9606a, given as a single agent to patients with solid tumors. The primary objectives are to investigate the safety and tolerability of DS-9606a and to determine the maximum tolerated dose (MTD) and recommended doses for expansion (RDE/RDEs) in advanced solid tumors.
The secondary objectives of the study are to assess the pharmacokinetic properties and immunogenicity of DS-9606a, investigate the objective response rate (ORR), duration of response (DOR), disease control rate (DCR), time to response (TTR) and progression free survival (PFS) of DS-9606a, according to RECIST v1.1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •At least 18 years old at the time of written informed consent
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- •Availability of archived tumor tissue samples; patients with germ cell tumors without archived tumor samples may be allowed with approval
- •Has a left ventricular ejection fraction (LVEF) ≥50% as determined by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before the start of study treatment
- •Adequate bone marrow and organ function within 7 days before the start of study treatment
- •Life expectancy ≥3 months
- •Adequate treatment washout period prior to start of study treatment
- •Male patients with female partners of childbearing potential and female patients of child-bearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study for at least 6 months (for males) and for at least 7 months (for females) after the last dose of study drug. Males must agree not to freeze or donate sperm throughout the study period for at least 6 months after final administration of study drug. Investigators will advise male patients on the conservation of sperm prior to study treatment. Females must agree not to donate or retrieve ova for own use throughout the study period and for at least 7 months after final study drug administration.
- •Histologically- or cytologically-documented locally advanced or metastatic cancers, including but not limited to: ovarian cancer (including fallopian tube and primary peritoneal carcinoma), germ cell tumors, uterine and endometrial cancers, pancreatic adenocarcinoma, non-squamous NSCLC, or gastric cancer
- •Disease progression with standard of care therapies for metastatic disease known to confer benefit, or are intolerant to or refuse standard treatment.
排除标准
- •Has history or current presence of central nervous system metastases, except for participants who have completed radiotherapy or surgery ≥4 weeks before the start of treatment, and fulfill all criteria (no evidence of disease progression in the CNS and no requirement for chronic corticosteroids) within 2 weeks before the start of treatment
- •Other invasive malignancy within 2 years; prior or concurrent non-invasive malignancies and/or patients with localized malignancies that were treated with curative intent who remain disease-free and are considered low likelihood for recurrence may be enrolled
- •History of myocardial infarction or unstable angina within 6 months before study treatment
- •Has a history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a serious cardiac arrhythmia requiring treatment
- •Has a corrected QT interval by Fridericia's formula (QTcF), of >470 ms based on the average of triplicate 12-lead electrocardiogram (ECG) per local read
- •Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- •Has an uncontrolled infection requiring ongoing or long-term therapy
- •Has a known active hepatitis or uncontrolled hepatitis B or C infection
研究组 & 干预措施
Dose Escalation: DS-9606a
Experimental
Participants who will receive an intravenous (IV) dose of DS9606a starting at 0.016 mg/kg every 3 weeks.
干预措施: DS-9606a (Drug)
结局指标
主要结局
Number of Participants with Dose-Limiting Toxicities (DLT) in Participants Receiving DS-9606a
时间窗: Cycle 1 Day 1 through Day 21 of Cycle 2 (each cycle is 21 days)
Number of Participants with Treatment-emergent Adverse Events (TEAEs) in Participants Receiving DS-9606a
时间窗: Cycle 1 Day 1 to 90 days after last dose, up to 42 months (each cycle is 21 days)
次要结局
- Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC)(Cycles 1-5, Day 1:pre-dose, end of flush, 4 hrs & 8 hrs post-dose (Cycles 1,3, &5 only); Cycle 1 & 3,Day 2; Cycle 1 & 3,Days 4,8, & 15; Cycle 2,Days 8 & 15;Cycle 4 & 6, & up to Cycle 10,Day 1 & pre-dose every cycle, up to 42 months (each cycle = 21 days))
- Pharmacokinetic Parameter Maximum Concentration (Cmax)(Cycles 1-5, Day 1:pre-dose, end of flush, 4 hrs & 8 hrs post-dose (Cycles 1,3, &5 only); Cycle 1 & 3,Day 2; Cycle 1 & 3,Days 4,8, & 15; Cycle 2,Days 8 & 15;Cycle 4 & 6, & up to Cycle 10,Day 1 & pre-dose every cycle, up to 42 months (each cycle = 21 days))
- Pharmacokinetic Parameter Trough Concentration (Ctrough)(Cycles 1-5, Day 1:pre-dose, end of flush, 4 hrs & 8 hrs post-dose (Cycles 1,3, &5 only); Cycle 1 & 3,Day 2; Cycle 1 & 3,Days 4,8, & 15; Cycle 2,Days 8 & 15;Cycle 4 & 6, & up to Cycle 10,Day 1 & pre-dose every cycle, up to 42 months (each cycle = 21 days))
- Pharmacokinetic Parameter Time to Maximum Concentration (Tmax)(Cycles 1-5, Day 1:pre-dose, end of flush, 4 hrs & 8 hrs post-dose (Cycles 1,3, &5 only); Cycle 1 & 3,Day 2; Cycle 1 & 3,Days 4,8, & 15; Cycle 2,Days 8 & 15;Cycle 4 & 6, & up to Cycle 10,Day 1 & pre-dose every cycle, up to 42 months (each cycle = 21 days))
- Overall Response Rate of DS-9606a as Assessed by the Investigator in Participants Receiving DS-9606a(Cycle 1 Day 1 and then every 6 weeks for 24 weeks, and then every 12 weeks, up to 42 months (each cycle is 21 days))
- Duration of Response (DoR) as Assessed by the Investigator in Participants Receiving DS-9606a(Cycle 1 Day 1 and then every 6 weeks for 24 weeks, and then every 12 weeks, up to 42 months (each cycle is 21 days))
- Disease Control Rate (DCR) as Assessed by the Investigator in Participants Receiving DS-9606a(Cycle 1 Day 1 and then every 6 weeks for 24 weeks, and then every 12 weeks, up to 42 months (each cycle is 21 days))
- Time to Response (TTR) as Assessed by the Investigator in Participants Receiving DS-9606a(Cycle 1 Day 1 and then every 6 weeks for 24 weeks, and then every 12 weeks, up to 42 months (each cycle is 21 days))
- Progression-free Survival (PFS) as Assessed by the Investigator in Participants Receiving DS-9606a(Cycle 1 Day 1 and then every 6 weeks for 24 weeks, and then every 12 weeks, up to 42 months (each cycle is 21 days))
- Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Percentage of Participants Who Have Treatment-emergent ADA(Cycle 1 Days 1 and 15, Cycles 2 and 3 Day 1, Cycle 4 Day 1 and every 4 cycles thereafter on Day 1, up to 42 months (each cycle is 21 days))
研究者
研究点 (7)
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