NCT07362888招募中1 期
A First-in-Human, Phase 1a/1b, Open-Label Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of the Antibody Drug Conjugate ADCE-B05 in Patients With Advanced Solid Tumors
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Adcendo ApS
- 入组人数
- 180
- 试验地点
- 7
- 主要终点
- Determine the MTD/maximum administered dose of ADCE-B05
研究概览
简要总结
The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the Recommended Expansion Dose and the safety and tolerability of ADCE-B05 when given as a single therapy over a range of different dose levels.
详细描述
Safety and tolerability will be evaluated by incidence of DLTs. Efficacy will be evaluated by antitumor activity: ORR, DOR, PFR, and TTR per RECIST v 1.1
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Histologically or cytologically confirmed diagnosis of solid tumor
- •Advanced disease (i.e., unresectable locally advanced or metastatic) and refractory to, intolerant of, or ineligible for approved therapies
- •Radiologically or clinically determined progressive disease during or after most recent line of therapy
- •Measurable disease per RECIST 1.1
- •ECOG performance status of 0 or 1
- •Adequate hematological and biochemical parameters
- •A male patient must agree to use barrier contraception during the treatment period and for at least 4 months after the last infusion of study treatment, and refrain from donating sperm during this period. Male patients with a pregnant partner must practice sexual abstinence or use a barrier method of contraception (e.g., condom) to prevent exposure of the fetus or neonate
- •A female patient who is not pregnant, not breast feeding, and either not a woman of childbearing potential (WOCBP) or agrees to follow the contraceptive guidance during the treatment period and for at least 7 months after last infusion of study treatment
排除标准
- •Treatment with systemic anticancer therapy, including any investigational agent within 3 weeks or 5 half-lives (whichever is shorter) prior to study treatment administration
- •Prior treatment with an ADC containing a topoisomerase I inhibitor payload
- •Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement for which treatment is required
- •Other malignancy
- •Major surgical procedure or significant traumatic injury within 28 days prior to study drug administration
- •Ongoing systemic infection requiring treatment with antibiotics, antivirals, or antimycotics, other than prophylactic treatment
- •Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1
- •Clinically significant cardiovascular disease
- •Acute infection with human immunodeficiency virus (HIV)-1 or HIV-2
- •Current active liver disease due to hepatitis B or hepatitis C
- •History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis or pulmonary lymphangitic carcinomatosis
研究组 & 干预措施
ADCE-B05
Experimental
Dose escalation followed by a dose expansion phase. ADCE-B05 is administered intravenously on a 3 weekly dosing cycle
干预措施: ADCE-B05 (Drug)
结局指标
主要结局
Determine the MTD/maximum administered dose of ADCE-B05
时间窗: From enrollment to the end of Phase 1a (Approximately 11 months after enrollment)
Incidence of dose-limiting toxicities (DLTs)
Assess the safety and tolerability of ADCE-B05
时间窗: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Nature, incidence, severity, and causality of treatment-emergent adverse events (TEAEs) and changes from baseline in laboratory parameters using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0). Tolerability as assessed by TEAEs leading to dose interruption, reduction and/or discontinuation
次要结局
- Maximum concentration (Cmax)(Throughout the trial duration, completion expected approximately 18 months from completed enrollment)
- Time to maximum concentration (Tmax)(Throughout the trial duration, completion expected approximately 18 months from completed enrollment)
- Terminal half-life (T[1/2])(Throughout the trial duration, completion expected approximately 18 months from completed enrollment)
- Area under the concentration-time curve (AUC)(Throughout the trial duration, completion expected approximately 18 months from completed enrollment)
- Total antibody (TAb)(Throughout the trial duration, completion expected approximately 18 months from completed enrollment)
- Free (de-conjugated) payload(Throughout the trial duration, completion expected approximately 18 months from completed enrollment)
- Objective response rate (ORR)(Throughout the trial duration, completion expected approximately 18 months from completed enrollment)
- Duration of response (DOR)(Throughout the trial duration, completion expected approximately 18 months from completed enrollment)
- Progression-free survival (PFS)(Throughout the trial duration, completion expected approximately 18 months from completed enrollment)
- Disease Control Rate (DCR)(Throughout the trial duration, completion expected approximately 18 months from completed enrollment)
- Time to Response (TTR)(Throughout the trial duration, completion expected approximately 18 months from completed enrollment)
研究者
研究点 (7)
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