NCT07299747招募中1 期
A Phase I/IIa Clinical Study Evaluating the Bispecific Antibody-Drug Conjugate VBC103 Targeting Nectin-4 and TROP2 in Subjects With Advanced Malignant Solid Tumors
VelaVigo Bio Inc1 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2025年12月4日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Incidence of dose-limiting toxicities (DLT) as defined in the protocol
研究概览
简要总结
This study is a multicenter, open-label, multi-dose, first-in-human (FIH) Phase I/IIa study to determine the safety and tolerability of VBC103, as well as the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D), PK and further evaluate its efficacy.
详细描述
Protocol Version：V1.1 Version Date：2025-12-12
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
- •1.The subject or their legal representative is willing and able to sign a written ICF before initiating any study procedures.
- •2.Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has recurred or progressed during or after standard systemic therapy, or is intolerant to standard therapy, or lacks standard treatment options (applicable only to Phase I and Phase IIa Cohort 5).
- •3.At least one measurable lesion as assessed by the investigator per RECIST v1.
- •4.Adult male or female (defined as ≥18 years of age)
- •5.ECOG performance status score of 0-
- •6.LVEF ≥50% as measured by ECHO or MUGA within 28 days prior to enrollment.
- •7.Life expectancy exceeding 12 weeks.
- •8.Availability of archived tumor tissue samples or willingness to undergo biopsy sampling.
排除标准
- •1.Any unresolved ≥Grade 2 toxicity from prior anticancer therapy.
- •2.Known active keratitis or corneal ulcer.
- •3.History of interstitial lung disease (e.g., non-infectious interstitial pneumonia, pneumonitis,pulmonary fibrosis, or severe radiation pneumonitis), current interstitial lung disease, or suspected interstitial lung disease based on imaging during the screening period.
- •4.History of underlying pulmonary diseases, including but not limited to pulmonary embolism within 3 months prior to the start of investigational product, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, and other clinically significant pulmonary impairment or requiring supplemental oxygen, as well as any autoimmune, connective tissue, or inflammatory disease involving the lungs (such as rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.) and/or prior pneumonectomy (complete resection).
研究组 & 干预措施
Phase 1 (Dose Escalation and Backfill)，Phase 2（Dose optimization and Cohort Expansion）
Experimental
干预措施: VBC103 (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
时间窗: (DLT)From time of first dose of VBC103 to end of DLT period (approximately 21 days)
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Incidence of Serious Adverse Events
时间窗: From time of Informed Consent to 30 days post last dose of VBC103
Number of patients with serious adverse events by system organ class and preferred term
次要结局
- Objective Response Rate (ORR)(From date of first dose of VBC103 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years))
- Duration of Response (DOR)(From date of first dose of VBC103 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years))
- Pharmacokinetics of VBC103: Plasma PK concentrations(From date of first dose of VBC103 up until 30 days post last dose)
- Disease Control Rate (DCR) at 12 weeks(From date of first dose of VBC103 up until progression, or the last evaluable assessment in the absence of progression (for each patient this is expected to be measured at 12 weeks))
- Pharmacokinetics of VBC103: Maximum plasma concentration of the study drug (C-max)(From date of first dose of VBC103 up until 30 days post last dose)
- Pharmacokinetics of VBC103: Time to maximum plasma concentration of the study drug (T-max)(From date of first dose of VBC103 up until 30 days post last dose)
- Immunogenicity of VBC103: Anti-Drug Antibodies (ADA)(From date of first dose of VBC103 up until 30 days post last dose)
研究者
研究点 (1)
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