NCT05425940进行中（未招募）3 期
A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Exelixis
- 入组人数
- 901
- 试验地点
- 244
- 主要终点
- Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in All Randomized Participants
研究概览
简要总结
The primary purpose of this study is to evaluate XL092 + atezolizumab versus regorafenib in participants with microsatellite stable/microsatellite instability low (MSS/MSI-low) metastatic colorectal cancer (mCRC) who have progressed during, after or are intolerant to standard-of-care (SOC) therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Participants with histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
- •Documented rat sarcoma (RAS) status (mutant or wild-type [WT]), by tissue-based analysis.
- •Documented NOT to have microsatellite instability-high (MSI-high) or mismatch repair deficient (dMMR) CRC by tissue-based analysis.
- •Has received SOC anticancer therapies as prior therapy for metastatic CRC and has radiographically progressed, is refractory or intolerant to these therapies.
- •Systemic SOC anticancer therapy if approved and available in the country where the participant is randomized.
- •Radiographic progression during treatment with or within 4 months following the last dose of the most recent approved SOC chemotherapy regimen.
- •Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by the Investigator.
- •Available archival tumor biopsy material. If archival tissue is unavailable, must provide fresh tumor tissue biopsy prior to randomization.
- •Recovery to baseline or ≤ Grade 1 severity (common terminology criteria for adverse events [CTCAE] version 5) from adverse events (AEs) related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Adequate organ and marrow function.
- •Fertile participants and their partners must agree to use highly effective methods of contraception during the course of the study and after the last dose of treatment.
- •Females of childbearing potential must not be pregnant at screening.
排除标准
- •Prior treatment with XL092, regorafenib, trifluridine/tipiracil, or programmed cell death protein-1/and its ligand (PD-L1/PD-1) targeting immune checkpoint inhibitors (ICIs).
- •Receipt of a small molecule kinase inhibitor (including investigational agents) within 2 weeks before randomization.
- •Receipt of any type of anticancer antibody therapy, systemic chemotherapy, or hormonal anti-cancer therapy within 3 weeks (or bevacizumab within 4 weeks) before randomization.
- •Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before randomization.
- •Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before randomization.
- •Has uncontrolled, significant intercurrent or recent illness.
- •Major surgery (example, gastrointestinal (GI) surgery, removal or biopsy of brain metastasis) within 4 weeks prior to randomization.
- •Systemic treatment with, or any condition requiring, either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to randomization.
- •Corrected QT interval calculated by the Fridericia formula (QTcF) > 460 milliseconds (ms) within 10 days before randomization.
- •History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent.
- •Pregnant or lactating females.
- •Inability to swallow study treatment formulation, inability to receive IV administration, or presence of GI condition that might affect the absorption of study drug.
- •Previously identified allergy or hypersensitivity to components of the study treatment formulations.
- •Any other active malignancy or diagnosis of another malignancy within 2 years before randomization. Exceptions are noted in the protocol.
- •Administration of a live, attenuated vaccine within 30 days before randomization.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Regorafenib
Active Comparator
Participants with mCRC will receive active comparator of regorafenib.
干预措施: Regorafenib (Drug)
XL092 + Atezolizumab
Experimental
Participants with mCRC will receive XL092 + atezolizumab.
干预措施: XL092 (Drug)
XL092 + Atezolizumab
Experimental
Participants with mCRC will receive XL092 + atezolizumab.
干预措施: Atezolizumab (Drug)
结局指标
主要结局
Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in All Randomized Participants
时间窗: Up to 32 months
Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in Randomized Non-Liver Metastases (NLM) Participants
时间窗: Up to 32 months
次要结局
- Progression-Free Survival (PFS) as Assessed by the Investigator(Up to 26 months)
- Duration of Response (DOR) as Assessed by the Investigator(Up to 36 months)
- Objective Response Rate (ORR) as Assessed by the Investigator(Up to 36 months)
- Number of Participants with Treatment Emergent Adverse Events (TEAEs)(Up to 36 months)
- Maximum Observed Plasma Drug Concentration (Cmax) of XL092(Predose up to 72 hours postdose)
- Time to Maximum Observed Plasma Drug Concentration (Tmax) of XL092(Predose up to 72 hours postdose)
- Number of Participants who Develop Antidrug Antibodies (ADA) Against Atezolizumab(Up to 36 months)
研究者
研究点 (244)
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