An Open-Label, Multicenter, Phase 1/1b Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
- 试验地点
- 36
- 主要终点
- Incidence of Dose Limiting Toxicities (DLT)
研究概览
简要总结
This study is a first-in-human (FIH), Phase 1/1b, open-label, multicenter dose escalation and dose expansion study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of JANX008 in adult subjects with advanced or metastatic carcinoma expressing EGFR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects ≥18 years of age at the time of signing informed consent
- •Histologically or cytologically documented locally advanced or metastatic NSCLC, SCCHN, CRC, RCC, SCLC, PDAC, TNBC
- •Progressed or was intolerant to all available therapies known to confer clinical benefit appropriate for the tumor type
- •Adequate organ function
- •At least 1 measurable lesion per RECIST 1.1
排除标准
- •Treatment with anti-cancer therapy within 28 days or ≤5 elimination half-lives, whichever is earlier, before enrollment
- •Prior treatment with EGFR-targeted bispecific T cell engager or CAR-T cell therapy
- •Prior treatment with CD3 engaging bispecific antibodies
- •Clinically significant cardiovascular diseases
- •Active clinically significant infection (bacterial, viral, fungal, mycobacteria, or other)
- •On supplemental oxygen
- •Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment
研究组 & 干预措施
Backfill Expansion
Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at levels previously declared tolerable.
干预措施: JANX008 (Drug)
Dose Escalation
Subjects will be dosed weekly during each 21-day cycle. Dosage per cohort will increase to determine the maximum tolerable dose.
干预措施: JANX008 (Drug)
Expansion
Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at the preliminary recommended Phase 2 dose (RP2D).
干预措施: JANX008 (Drug)
结局指标
主要结局
Incidence of Dose Limiting Toxicities (DLT)
时间窗: 21 days
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
时间窗: Up to 4 years
Incidence of Clinically Significant Laboratory Abnormalities
时间窗: Up to 4 years
次要结局
- Number of participants who develop anti-drug antibodies against JANX008(Up to 4 years)
- Progression Free Survival(Up to 4 years)
- Maximum observed concentration of JANX008 (Cmax)(Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 4 years))
- Duration of Response(Up to 4 years)
- Correlation of EGFR expression level with anti-tumor activity and safety(Up to 4 years)
- Area under the concentration time curve from time 0 to last timepoint prior to next dose JANX008 (AUC last)(Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 4 years))
- Overall Response Rate(Up to 4 years)