Phase 1/2a Open-label Clinical Trial Evaluating VBC117, an EGFR and CDH17-directed Bi-specific Antibody Drug Conjugate, in Participants With Advanced Malignant Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 260
- 试验地点
- 12
- 主要终点
- Incidence of AEs
研究概览
简要总结
Detailed Description: This is a multicenter, open-label, multiple-dose, first in human(FIH) Phase 1/2a trial. The Phase 1 portion uses the Bayesian optimal interval (BOIN) design to escalate doses and determine the maximum tolerated dose(MTD) and/or recommended phase 2 dose(RP2D) with potential backfill cohorts. The Phase 2a portion consists of dose optimization followed by cohort expansion to confirm safety and tolerability and further evaluate the efficacy of the selected RP2D in selected solid tumor malignancies treated with VBC117.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •The participant or the participant's legally acceptable representative is willing and able to provide a written ICF before initiating any trial procedure.
- •Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor .
- •At least one measurable lesion as assessed by the investigator according to RECIST v1.1 criteria.
- •Male or female adults (defined as ≥ 18 years of age).
- •ECOG performance status 0-
- •Life expectancy greater than 12 weeks.
- •Archived tumor tissue sample available or able to undergo a fresh biopsy collection.
- •Adequate organ and bone marrow function.
排除标准
- •Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment.
- •Known or suspected brain metastases, or spinal cord compression.
- •Prior treatment with an ADC targeting EGFR x CDH17 bispecific ADC.
- •Prior treatment with any ADC carrying a topoisomerase I inhibitor (TOP1i) payload.
- •Has a medical history of interstitial lung diseases or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.
研究组 & 干预措施
VBC117 Dose Level 1
Phase 1 dose escalation and backfill: VBC117 at Dose Level 1
干预措施: VBC117 (Drug)
VBC117 Dose Level 2
Phase 1 dose escalation and backfill: VBC117 at Dose Level 2
干预措施: VBC117 (Drug)
VBC117 Dose Level 3
Phase 1 dose escalation and backfill: VBC117 at Dose Level 3
干预措施: VBC117 (Drug)
VBC117 Dose Level 4
Phase 1 dose escalation and backfill: VBC117 at Dose Level 4
干预措施: VBC117 (Drug)
VBC117 Dose Level 5
Phase 1 dose escalation and backfill: VBC117 at Dose Level 5
干预措施: VBC117 (Drug)
VBC117 Dose Level RP2D
Phase 2a expansion cohort: VBC117 at RP2D across tumor-specific cohorts
干预措施: VBC117 (Drug)
结局指标
主要结局
Incidence of AEs
时间窗: From time of Informed Consent to 30 days post last dose of VBC117
Number of patients with Adverse Events（AEs）by system organ class and preferred term
Incidence of DLTs
时间窗: From time of first dose of VBC117 to end of DLT period (approximately 21 days)
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Incidence of SAEs
时间窗: From time of Informed Consent to 30 days post last dose of VBC117
Number of patients with Serious Adverse Events(SAEs)by system organ class and preferred term
Incidence of TEAE leading to dose modification or discontinuation
时间窗: From time of Informed Consent to 30 days post last dose of VBC117
Number of patients with treatment-emergent adverse event (TEAE) leading to dose modification or discontinuation by system organ class and preferred term
objective response rate (ORR)
时间窗: From first dose of VBC117 to disease progression or death, up to approximately 2 years
The percentage or number of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours
次要结局
未报告次要终点