JPRN-jRCT2031200385已完成1 期
A phase I open-label dose escalation trial of BI 1701963 as monotherapy and in combination with BI 3011441 in patients with KRAS mutated advanced or metastatic solid tumours
WU HAOY0 个研究点目标入组 124 人开始时间: 2021年3月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 124
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Previously-identified activating KRAS mutation in tumour tissue prior to screening. Activating mutations may include but are not limited to: KRAS mutations in exon 2 (G12, G13), exon 3 (A59, Q61) and exon 4 (K117, A146). See Table 10.2: 3 for a list of alleles. An exemplary list of tests used for historical local determination of KRAS mutation status in international or country-specific certified laboratory (e.g. CAP/CLISA or ISO) is summarized in Table 10.2: 4.
- •2.Provision of archival tumour tissue, if available, to confirm retrospectively KRAS mutation status and for biomarker assessment
- •3.At least one target lesion that can be measured per RECIST version 1.1. In patients who only have one target lesion, and a biopsy of the lesion is required, the baseline imaging must be performed at the earliest two weeks after the biopsy.
- •4.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
- •5.Adequate organ function at screening as follows:
- •a)Absolute neutrophil count (ANC)>=1.5x109/L; hemoglobin>=9.0 g/dL;platelets>=100x109/L without the use of haematopoietic growth factors
- •b)Total bilirubin =<1.5 times the upper limit of normal (ULN), or=<4xULN for patients who are known to have gilberts syndrome.
- •c)Creatinine =<1.5xULN. If creatinine is >1.5xULN, patient is eligible if concurrent glomerular filtration rate (GFR)>=50 mL/min (measured or calculated by CKD-EPI formula).
- •d)Aspartate transaminase (AST) and alanine transaminase (ALT)=<3 x ULN if no demonstrable liver metastases, or =< 5xULN if transaminase elevation is attributable to liver metastases.
- •6.Age >=18 years of age, or over the legal age of consent as required by local legislation at informed consent.
- •7.Recovery from any previous therapy related toxicity to Common Terminology Criteria for Adverse Events (CTCAE) Grade =<1 at Cycle 1 Day 1 (except for alopecia, stable sensory neuropathy must be CTCAE Grade =<2) before the first dose.
- •8.Signed and dated written informed consent in accordance with GCP and local legislation prior to admission to the trial
- •9.Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, prior to trial entry and for the duration of trial participation and for a minimum time period after treatment has ended, i.e. at least 4 months for BI 1701963 monotherapy and combination treatment with BI 3011441
- •10.Women of childbearing potential1 who are not surgically sterilized must have a negative serum pregnancy test completed during the Screening period
- •Monotherapy and combination therapy dose escalation (Parts A and B)
- •11.Willingness to undergo pre- and on-treatment tumour biopsies for pharmacodynamics and biomarker assessment. Patients can be enrolled without tumour biopsy upon agreement between the investigator and the sponsor if tumour biopsy is clinically contraindicated.
- •12.Documented disease progression despite appropriate prior standard therapies2 or for whom no standard therapy exists for their tumour type and disease stage
- •Combination therapy dose confirmation and expansion part (Parts C1 and D1)
- •13.Pathologically confirmed diagnosis of locally advanced (stage IIIB/C) or metastatic (stage IVA/B) adenocarcinoma of the lung. Patients must have progressed after having received at least two lines of stand
排除标准
- •1.Previous anticancer chemotherapy or anticancer immunotherapy within 3 weeks of the first administration of trial drug. Previous anticancer hormonal treatment within 2 weeks of the first administration of trial drugs.
- •2.Previous treatment with RAS, MAPK or SOS1 targeting agents
- •3.Radiotherapy within 4 weeks prior to start of treatment except as follows
- •-Palliative radiotherapy to regions other than the chest is allowed up to 2 weeks prior to start of treatment
- •-Single dose palliative radiotherapy for symptomatic metastasis within 2 weeks prior to start of treatment may be allowed but must be discussed with the sponsor.
- •4.Major surgery (major according to the investigator assessment) performed within 4 weeks prior to start of treatment or planned during the projected course of the trial, e.g. hip replacement.
- •5.Previous treatment with any investigational agent(s) or targeted treatment within 28 days prior to start of treatment.
- •6.Known history of hypersensitivity to any of the excipients of BI 1701963 tablets
- •7.History or presence of cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of >=3, unstable angina or poorly controlled arrhythmia which are considered clinically relevant by the investigator; myocardial infarction within 6 months prior to start of treatment. Uncontrolled hypertension is defined as: Blood pressure measured in a rested and relaxed condition, where systolic BP >=140 mmHg, or diastolic BP >=90 mmHg, with or without medication.
- •8.Left ventricular ejection fraction (LVEF)<50%
- •9.Congenital long QT prolongation syndrome or mean resting corrected QT interval (QTcF)>470 msec at screening.
- •10.Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patients ability to comply with the trial or interfere with the evaluation of the efficacy and safety of the trial medications.
- •11.Previous or concomitant malignancies at other sites, except effectively treated
- •-Non-melanoma skin cancers
- •-Carcinoma in situ of the cervix
- •-Ductal carcinoma in situ
- •-Other malignancy that has been in remission for more than 3 years and is considered to be cured.
- •12.Leptomeningeal carcinomatosis.
- •13.Presence or history of uncontrolled or symptomatic brain metastases, unless considered stable by the investigator and local therapy was completed. Use of corticosteroids is allowed if the dose was stable for at least 4 weeks. Inclusion of patients with newly identified brain metastasis/es at screening will be allowed if patients are asymptomatic.
- •-Patients who have resected brain metastases, or have received radiation therapy that finished at least 4 weeks (whole brain radiation) or 2 weeks (stereotactic body radiotherapy) prior to treatment of the trial are considered eligible if they meet all of the following criteria:
- •a) Residual neurological symptoms CTCAE Grade=<2
- •b) Are taking stable doses of dexamethasone, if applicable
- •c) Follow-up magnetic resonance imaging (MRI) shows no new lesions.
- •14.History (including current) of interstitial lung disease.
- •15.Known active hepatitis B infection (defined as presence of Hepatisis B surface antigen (HBs-Ag) and IgM anti-HBc, with or without HBeAg in acute hepatitis, and persistence of HBsAg for at least 6 months, with or without concurrent HBeAg in chronic hepatitis); active hepatitis C infection (defined as presence of Hep C RNA); and/or known HIV carrier.
- •16.Active infectious disease which puts
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