NCT07136779招募中1 期
PHASE 1/2A OPEN-LABEL CLINICAL TRIAL EVALUATING VBC101, AN EGFR AND CMET TARGETED BI-SPECIFIC ANTIBODY DRUG CONJUGATE, IN PARTICIPANTS WITH ADVANCED SOLID TUMOR MALIGNANCIES
VelaVigo Bio Inc5 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2025年9月23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
- 310
- 试验地点
- 5
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion adopts an accelerated titration for the first dose level, followed by BOIN design to identify the MTD and/or RP2D with potential backfill cohorts. The Phase 2a portion consists of dose optimization followed by cohort expansion to confirm safety and tolerability and to further evaluate the efficacy of the selected RP2D in selected solid tumor malignancies for VBC101.
详细描述
Protocol Version：V1.3 Version Date：2026-04-20
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
- •A participant must meet all of the following inclusion criteria to be eligible to participate in this trial:
- •1. The participant or the participant's legally acceptable representative is willing and able to provide a written ICF before initiating any trial procedure.
- •2. Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or is intolerable with standard treatment, or for which no standard treatment is available
- •3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1criteria
- •4. Male or female adults (defined as ≥ 18 years of age)
- •5. ECOG performance status 0-1
- •6. Has LVEF ≥ 50% by either ECHO or MUGA within 28 days before enrollment.
- •7. Life expectancy greater than 12 weeks
- •8. Archived tumor tissue sample available or able to undergo a fresh biopsy collection.
- •9. Adequate organ and bone marrow function
- •10. Participants must meet the minimum washout period requirements before the first dose of investigational drug
排除标准
- •1. Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment, except for alopecia, neuropathy, or skin pigmentation changes. Participants with chronic but stable Grade 2 toxicities may be allowed to enroll after agreement between the study investigator and the Sponsor's Medical Monitor.
- •2. Known or suspected brain metastases, or spinal cord compression, unless the condition has been treated, asymptomatic, and has been stable without requiring escalating doses of corticosteroids (equivalent to ≤10 mg/day prednisone) or anti-convulsant medications for at least four weeks prior for the first dose of investigational drug.
- •3. Prior treatment with an ADC targeting EGFR and/or cMet (including VBC101)
- •4. Prior treatment with any ADC carrying a TOP1i payload (including prior VBC101).
- •5. Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.
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: VBC101 (Drug)
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: From time of Informed Consent to 30 days post last dose of VBC101
Number of patients with adverse events by system organ class and preferred term
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
时间窗: (DLT)From time of first dose of VBC101 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 VBC101
Number of patients with serious adverse events by system organ class and preferred term
Incidence of Adverse Events(AEs)
时间窗: From time of Informed Consent to 30 days post last dose of VBC101
Number of patients with adverse events by system organ class and preferred term
次要结局
- Duration of Response (DoR)(From date of first dose of VBC101 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years))
- Disease Control Rate (DCR) at 12 weeks(From date of first dose of VBC101 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))
- Progression free Survival (PFS)(From date of first dose of VBC101 up until date of progression or death due to any cause (approximately 2 years))
- Objective Response Rate (ORR)(From date of first dose of VBC101 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years))
- Overall Survival (OS)(From date of first dose of VBC101 up until the date of death due to any cause (approximately 2 years))
- Pharmacokinetics of VBC101: Plasma PK concentrations(From date of first dose of VBC101 up until 30 days post last dose)
- Pharmacokinetics of VBC101: Area under the concentration time curve (AUC)(From date of first dose of VBC101 up until 30 days post last dose)
- Pharmacokinetics of VBC101: Time to maximum plasma concentration of the study drug (T-max)(From date of first dose of VBC101 up until 30 days post last dose)
- Pharmacokinetics of VBC101: Maximum plasma concentration of the study drug (C-max)(From date of first dose of VBC101 up until 30 days post last dose)
- Pharmacokinetics of VBC101: Half-life(From date of first dose of VBC101 up until 30 days post last dose)
- Immunogenicity of VBC101: Anti-Drug Antibodies (ADA)(From date of first dose of VBC101 up until 30 days post last dose)
研究者
研究点 (5)
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