EUCTR2021-003254-23-ES进行中（未招募）1 期
A Phase 2, Open-Label, Multicenter Study of the Combination of RMC-4630 and Sotorasib for Non-Small Cell Lung Cancer Subjects with KRASG12CMutation After Failure of Prior Standard Therapies
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject must be =18 years of age at the time of signing the informed consent form (ICF).
- •2. Subject must have pathologically documented, locally advanced or metastatic KRASG12C
- •NSCLC (not amenable to curative surgery) that has progressed on prior standard therapies (no more than 3 prior lines of therapies are allowed), as follows:
- •a. Subject with actionable oncogenic driver mutations (eg, epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase [ALK], and ROS1) must have received standard-of-care anticancer treatments, including approved drugs for oncogenic drivers in their tumor type.
- •b. Subject’s tumor must harbor a KRASG12C mutation assessed by a CLIA-/CAP-certified laboratory.
- •3. Subject must have measurable disease per RECIST v1.1, criteria.
- •4. Subject must have a life expectancy of at least 3 months.
- •5. The subject’s ECOG PS of 0 to 1 with no deterioration in PS 2 weeks prior to C1D1. Rescreening is required if PS is >1 for any reason prior to C1D1.
- •6. Subject must have the ability to typically ingest and retain PO medications.
- •7. Subject must have adequate hematological and biological function, as follows:
- •a. Bone marrow function:
- •i. Absolute neutrophil count (ANC) =1.5 × 109/L without use of hematopoietic growth factors
- •ii. Hemoglobin =9 g/dL; subject must not have received a red blood cell (RBC) transfusion within 28 days of Screening
- •iii. Platelets =100 × 109/L; subject must not have received a platelet
- •transfusion within 14 days of Screening
- •b. Subject must have hepatic function as follows:
- •i. AST and ALT =2.5 × upper limit of normal (ULN)
- •ii. Bilirubin =1.5 × ULN (<2.0 × ULN for subject with documented Gilbert’s
- •syndrome or <3.0 × ULN for subject for whom the indirect bilirubin level suggests an extrahepatic source of elevation)
- •c. Subject must have renal function as follows: Serum creatinine =1.5 × ULN or creatinine clearance (CrCl) of >50 mL/min (using the Cockcroft-Gault formula or 24-hour urine collection)
- •d. Subject must have coagulation function as follows: Prothrombin time (PT)/international normalized ratio (INR) and activated partial thromboplastin time (aPTT)/partial thromboplastin time (PTT) <1.3 × ULN, or within target range if taking prophylactic anticoagulant(s).
- •8. Female subject is eligible to participate if she meets the following criteria:
- •a. Is not a woman of childbearing potential (WOCBP), OR
- •b. Is a WOCBP and using a contraceptive method that is highly effective (ie, with a failure rate of <1% per year), preferably with low user dependency, during the treatment period and for at least 2 months after the last dose of study treatment and agree not to donate eggs (ie, ova and oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study treatment. Hormonal contraception efficacy may potentially be decreased due to interaction with sotorasib; therefore, male condoms must be used in addition to any hormonal-based contraception methods.
- •9. Male subject is eligible to participate if he agrees to the following during the treatment period and for =3 months after the last dose of study treatment:
- •a) Refrains from donating sperm (any donation of sperm should be conducted prior to study start) PLUS, either:
- •b) Abstain from intercourse as his preferred and usual lifestyle (abstinent on a longterm and persistent basis) and agree to remain abstinent, OR
排除标准
- •Subjects with:
- •1.Primary central nervous system tumor(s)
- •2 Have known or suspected leptomeningeal or brain metastases or spinal cord compression. However, a subject who was previously treated for these conditions who have had stable CNS diseases are eligible to participate in the study, as long as stable disease is documented by a brain MRI performed within 28-days (D) of C1D1.
- •3 Have any of the following cardiac abnormalities:
- •a Medically uncontrolled hypertension,
- •b Congestive heart failure Class =2,
- •c Acute coronary syndrome; myocardial infarction within 6M of ICF,
- •d History or evidence of current, uncontrolled, clinically significant, unstable arrhythmias: i Subject with medically controlled atrial fibrillation >1M prior to Study Day 1 is eligible. ii Subject who has a pacemaker in place to control atrial arrhythmias is a candidate for the study.
- •e History of congenital long QT syndrome or prolonged corrected QT interval (QTc) >470 msec for females and > 450 msec for males using Fridericia’s formula or uncorrectable abnormalities in serum electrolytes: i Subject may use average of triplicate readings for assessing QTc interval. ii Subject with an implantable defibrillator is not eligible to participate in the study
- •f Current cardiomyopathy or history within in the past 12M prior to ICF
- •g Baseline left ventricular ejection fraction below the institutional lower limit
- •of normal or <50%, whichever is lower.
- •4 Any prior history of (or active) ILD or pneumonitis, or prior thoracic radiotherapy within 2M of enrollment.
- •5 Subject has a history or current evidence of retinal pigment epithelial detachment (RPED), central serous retinopathy, retinal vein occlusion (RVO), or predisposing factors to RPED or RVO
- •6 Visible retinal pathology as assessed on ophthalmic examination that is considered a significant risk factor for RVO or RPED by ophthalmologist
- •7 Have of Grade =2 proteinuria
- •8 Have a history of cerebrovascular accident or transient ischemic attack previous 6M of signing the ICF
- •9 Have a known activating SHP2 mutation
- •10 Have an active autoimmune disease requiring systemic treatment within the past 2 years of signing the ICF; includes current autoimmune sequelae or previous Grade >2 autoimmune sequelae from checkpoint inhibitors or other immunomodulatory treatments that require systemic therapy. Subject with autoimmune endocrine disorder on hormonal supplementation may be enrolled, even if Grade >2 upon initial presentation,
- •11 Have known HIV infection
- •12 Have an active/chronic hepatitis B or C virus infection
- •13 Have a known impairment of gastrointestinal function that may significantly alter the absorption of RMC-4630
- •14 Have a history of severe allergic reactions
- •15 Have major surgical procedures =28 D or non-study-related minor procedures =7D prior to Cycle 1 Day 1 (C1D1)
- •16 Have any clinically significant concurrent medical condition that would, in the opinion of the investigator, and/or impact their ability to comply with the protocol. Any subject who had a pulmonary embolism within 3M of C1D1 will also be excluded.
- •17 Have had prior therapy with one or both of the following agents, meets criteria for exclusion: a KRASG12C inhibitor and b. SHP2 inhibitor
- •18 Have had treatment with chemotherapy or biologics/monoclonal antibodies <21D or 5 half-lives before C1D1
- •19 Have had treatment with non-thoracic radiation therapy <14D before C1D1
- •20 Have had treatment with tyrosine kinase inhibitor (TKI), hormonal therapy <7D before C1
研究者
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