NCT07793253尚未招募2 期
A Multi-Institutional Phase 2 Evaluation of Daraxonrasib in Recurrent KRAS-Mutant Biliary Tract Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2026年11月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Objective Response (ORR)
研究概览
简要总结
The purpose of this study is to evaluate the anti-tumor efficacy of daraxonrasib monotherapy in patients with unresectable or advanced/metastatic, KRAS-mutant BTC who have progressed on or are intolerant of 1st line systemic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Unresectable locally advanced or metastatic histologically or cytologically confirmed biliary tract cancer
- •Must have documented disease progression or intolerance of one prior systemic chemotherapy regimen (with or without immunotherapy) for unresectable and/or advanced stage disease.
- •Age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 -
- •Have measurable disease based on RECIST 1.
- •Documented KRAS mutation
- •Adequate organ and marrow function defined by study-specified laboratory tests and procedures.
- •Willingness to provide serial tissue and blood samples for mandatory translational research.
- •Evidence of post-menopausal status or a negative pregnancy test in women of childbearing potential (WOCBP).
- •All participants must agree to use acceptable form of birth control while on study.
- •Ability to take oral medications and willingness to keep daily adherence record in a medication diary.
- •Must understand the study regimen, its requirements, risks and discomforts and is able and willing to sign the informed consent form in accordance with regulatory and institutional guidelines.
排除标准
- •Any systemic anti-cancer therapy for advanced BTC within 3 weeks of enrollment or 5 half-lives of the drug, whichever is shorter.
- •Prior treatment with any KRAS, RTK, or MEK inhibitor or other RAS-pathway targeting signal transduction inhibitor agents
- •Major surgery, extended field radiotherapy, or local regional therapy within 4 weeks from first dose of study drug, limited field radiotherapy within 2 weeks of first dose, or failure to recover from side effects of these prior therapies
- •Known additional malignancy that is progressing and requires active treatment.
- •Receiving concomitant medications that interfere with Daraxonrasib.
- •Significant cardiovascular disease.
- •Significant cardiac conduction abnormalities.
- •Impaired gastrointestinal function.
- •Active autoimmune disease
- •Clinically active ascites.
- •Active uncontrolled infection requiring systemic therapy within 72 hours prior to C1D
- •Known history of human immunodeficiency virus (HIV).
- •Active or chronic hepatitis B or hepatitis C.
- •Known history of central nervous system (CNS) metastases and/or history of uncontrolled seizures.
- •Any uncontrolled acute or chronic medical illness.
- •History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- •Pregnant or breastfeeding
- •Patient is unwilling or unable to follow the study schedule for any reason.
- •Has known psychiatric or substance use disorder that would interfere with cooperation with the requirements of the trial.
研究组 & 干预措施
Daraxonrasib
Experimental
干预措施: Daraxonrasib (Drug)
结局指标
主要结局
Objective Response (ORR)
时间窗: 4 years
ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Subjects who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders.
次要结局
- Duration of response (DOR)(4 years)
- Disease control rate (DCR)(4 years)
- Overall Survival (OS)(4 years)
- Progression free survival (PFS)(4 years)
- Unacceptable Toxicities(4 years)
研究者
研究点 (1)
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