A Phase 2, Randomized Study to Evaluate Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination with Fluorouracil, Folinic Acid, and Bevacizumab in Previously Treated Subjects with Unresectable Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 61
- 试验地点
- 64
- 主要终点
- Objective Response as assessed by the investigator
研究概览
简要总结
- To optimize ABBV-400 dose in combination with 5-FU, folinic acid, and bevacizumab to determine the RP3D regimen for the combination.
- To evaluate the efficacy as measured by OR and PFS of ABBV-400 in combination with 5-FU, folinic acid, and bevacizumab
- To evaluate the safety and tolerability of ABBV-400 in combination with 5-FU, folinic acid, and bevacizumab
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 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of histologically or cytologically confirmed unresectable metastatic colorectal cancer (mCRC).
- •Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
排除标准
- •Harbor the BRAF V600E mutation.
- •dMMR+/MSI-H.
- •Progressed on only one first-line (1L) systemic treatment of combination chemotherapy in the metastatic setting with or without targeted therapy.
- •Received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-400.
研究组 & 干预措施
Stage 1: ABBV-400+FFB B
Participants will receive escalating ABBV-400 in combination with FFB on dose schedule B as part of the safety lead in, during the 3 year study duration.
干预措施: FOLINIC ACID (Drug)
Stage 1: ABBV-400+FFB A
Participants will receive escalating ABBV-400 in combination with Fluorouracil, Folinic Acid, and Bevacizumab (FFB) on dose schedule A as part of the safety lead in, during the 3 year study duration.
干预措施: ABBV-400 (Drug)
Stage 1: ABBV-400+FFB A
Participants will receive escalating ABBV-400 in combination with Fluorouracil, Folinic Acid, and Bevacizumab (FFB) on dose schedule A as part of the safety lead in, during the 3 year study duration.
干预措施: BEVACIZUMAB (Drug)
Stage 1: ABBV-400+FFB A
Participants will receive escalating ABBV-400 in combination with Fluorouracil, Folinic Acid, and Bevacizumab (FFB) on dose schedule A as part of the safety lead in, during the 3 year study duration.
干预措施: FOLINIC ACID (Drug)
Stage 1: ABBV-400+FFB A
Participants will receive escalating ABBV-400 in combination with Fluorouracil, Folinic Acid, and Bevacizumab (FFB) on dose schedule A as part of the safety lead in, during the 3 year study duration.
干预措施: FLUOROURACIL (Drug)
Stage 1: ABBV-400+FFB B
Participants will receive escalating ABBV-400 in combination with FFB on dose schedule B as part of the safety lead in, during the 3 year study duration.
干预措施: ABBV-400 (Drug)
Stage 1: ABBV-400+FFB B
Participants will receive escalating ABBV-400 in combination with FFB on dose schedule B as part of the safety lead in, during the 3 year study duration.
干预措施: BEVACIZUMAB (Drug)
Stage 1: ABBV-400+FFB B
Participants will receive escalating ABBV-400 in combination with FFB on dose schedule B as part of the safety lead in, during the 3 year study duration.
干预措施: FLUOROURACIL (Drug)
Stage 2: ABBV-400+FFB A Low
Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration.
干预措施: ABBV-400 (Drug)
Stage 2: ABBV-400+FFB A Low
Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration.
干预措施: BEVACIZUMAB (Drug)
Stage 2: ABBV-400+FFB A Low
Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration.
干预措施: FOLINIC ACID (Drug)
Stage 2: ABBV-400+FFB A Low
Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration.
干预措施: FLUOROURACIL (Drug)
Stage 2: ABBV-400+FFB A High
Participants will receive ABBV-400 in combination with FFB at the high dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration.
干预措施: ABBV-400 (Drug)
Stage 2: ABBV-400+FFB A High
Participants will receive ABBV-400 in combination with FFB at the high dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration.
干预措施: BEVACIZUMAB (Drug)
Stage 2: ABBV-400+FFB A High
Participants will receive ABBV-400 in combination with FFB at the high dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration.
干预措施: FOLINIC ACID (Drug)
Stage 2: ABBV-400+FFB A High
Participants will receive ABBV-400 in combination with FFB at the high dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration.
干预措施: FLUOROURACIL (Drug)
Stage 2: FFB+Irinotecan (Standard of Care [SOC])
Participants will receive SOC during the 3 year study duration.
干预措施: BEVACIZUMAB (Drug)
Stage 2: FFB+Irinotecan (Standard of Care [SOC])
Participants will receive SOC during the 3 year study duration.
干预措施: FOLINIC ACID (Drug)
Stage 2: FFB+Irinotecan (Standard of Care [SOC])
Participants will receive SOC during the 3 year study duration.
干预措施: FLUOROURACIL (Drug)
Stage 2: FFB+Irinotecan (Standard of Care [SOC])
Participants will receive SOC during the 3 year study duration.
干预措施: IRINOTECAN (Drug)
Stage 3: ABBV-400+FFB B Low
Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule A as part of the dose optimization/expansion, during the 3 year study duration.
干预措施: ABBV-400 (Drug)
Stage 3: ABBV-400+FFB B Low
Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule A as part of the dose optimization/expansion, during the 3 year study duration.
干预措施: BEVACIZUMAB (Drug)
Stage 3: ABBV-400+FFB B Low
Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule A as part of the dose optimization/expansion, during the 3 year study duration.
干预措施: FOLINIC ACID (Drug)
Stage 3: ABBV-400+FFB B Low
Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule A as part of the dose optimization/expansion, during the 3 year study duration.
干预措施: FLUOROURACIL (Drug)
Stage 3: ABBV-400+Bevacizumab C High
Participants will receive ABBV-400 in combination with Bevacizumab at the high dose determined in the safety lead in on dose schedule C as part of the dose optimization/expansion, during the 3 year study duration.
干预措施: ABBV-400 (Drug)
Stage 3: ABBV-400+Bevacizumab C High
Participants will receive ABBV-400 in combination with Bevacizumab at the high dose determined in the safety lead in on dose schedule C as part of the dose optimization/expansion, during the 3 year study duration.
干预措施: BEVACIZUMAB (Drug)
结局指标
主要结局
Objective Response as assessed by the investigator
Objective Response as assessed by the investigator
Progression Free Survival (PFS) as assessed by the investigator
Progression Free Survival (PFS) as assessed by the investigator
次要结局
- Duration of Response (DOR) as assessed by the investigator
- Overall Survival (OS)
- Best Overall Response (BOR) as assessed by the investigator
研究者
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