2024-512981-33-00招募中2 期
A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations with Telisotuzumab Adizutecan in Subjects with Metastatic Colorectal Cancer (AndroMETa-CRC-533)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 34
- 主要终点
- Substudy 1 and 2: Objective response as assessed by the investigator: confirmed Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST, version 1.1. A repeat assessment must confirm response at least 28 days from the first documented response.
研究概览
简要总结
- To evaluate the efficacy of telisotuzumab adizutecan combinations as compared to standard of care treatment in Metastatic colorectal cancer (mCRC).
- To evaluate the safety and tolerability of telisotuzumab adizutecan combinations.
- To optimize the telisotuzumab adizutecan dose in combination regimens to determine the recommended Phase 3 dose (RP3D) in applicable substudies.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Substudy 1 and 2: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Substudy 1 and 2: QTc < 470 msec (using Fridericia's correction), no Grade 3 arrythmia, and no other clinically significant cardiac abnormalities.
- •Substudy 1 and 2: Participant has histologically or cytologically confirmed mCRC.
- •Substudy 1 and 2: Participant has measurable disease per RECIST v1.
- •Substudy 2: Left sided primary tumor
排除标准
- •Substudy 1 and 2: Prior systemic therapy for mCRC.
- •Substudy 1 and 2: History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis that required treatment with systemic steroids, or idiopathic pneumonitis.
- •Substudy 1 and 2: History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%).
- •Substudy 2: History of treatment with any anti-EGFR treatments (cetuximab or panitumumab).
结局指标
主要结局
Substudy 1 and 2: Objective response as assessed by the investigator: confirmed Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST, version 1.1. A repeat assessment must confirm response at least 28 days from the first documented response.
Substudy 1 and 2: Objective response as assessed by the investigator: confirmed Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST, version 1.1. A repeat assessment must confirm response at least 28 days from the first documented response.
次要结局
- Substudy 1 and 2: Progression-Free Survival as assessed by the investigator: PFS is defined as the time from the first dose of study treatment to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the investigator or death from any cause, whichever occurs earlier.
- Substudy 1 and 2: DOR as assessed by the investigator: The time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST v1.1 as determined by the investigator or death from any cause, whichever occurs first. DOR is defined for subjects with confirmed CR/PR.
- Substudy 1 and 2: Overall survival: defined as the time from first dose of study treatment to the event of death from any cause.
- Substudy 1 and 2: Disease Control as assessed by the investigator: best overall response of confirmed CR or confirmed PR, or Stable Disease (SD) based on RECIST, version 1.1 as determined by the investigator.
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (34)
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