JPRN-jRCT2031210652招募中1 期
An open label, Phase I dose-finding study of BI 765179 as monotherapy and in combination with ezabenlimab (BI 754091) in patients with advanced solid cancers
Igarashi Haruki0 个研究点目标入组 127 人开始时间: 2022年3月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 127
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Patients with locally advanced, unresectable or metastatic solid tumors who are either refractory after standard therapy for the disease or for whom standard therapy is not appropriate
- •2.Tumor with expected high expression of FAP of the following histologies:
- •oNon-small cell lung carcinoma (NSCLC)
- •oGastric cancer
- •oEsophageal adenocarcinoma or squamous cell carcinoma
- •oUrothelial bladder carcinoma
- •oOral squamous cell cancer
- •oCutaneous malignant melanoma
- •oCutaneous squamous cell carcinoma
- •oHepatocellular carcinoma
- •oPancreatic adenocarcinoma
- •oColorectal cancer
- •oMalignant pleural mesothelioma
- •oCervical squamous cell cancer
- •oOvarian carcinoma
- •oTriple-negative breast cancer
- •3.At least 18 years of age at the time of the consent or over the legal age of consent in countries where that is greater than 18 years
- •4.Signed and dated, written informed consent (IC) in accordance with ICH-GCP and local legislation prior to admission to the trial
- •5.At least one measurable lesion outside of CNS as defined per modified RECIST 1.1
- •6.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •7.Adequate liver, bone marrow and renal organ function as follows:
- •Haematological:
- •Absolute neutrophil count: >=1.0 x 109 /L (>=1.0 x 1000/ul or >=1.0 x 1000/mm3) (without G-CSF support within the last 3 weeks)
- •Platelets:>=100 x 109 /L (>=100 x 1000/ul or >=100 x 1000/mm3)
- •Haemoglobin:>=9.0 g/dL or >5.6 mmol/L (red blood cell transfusion allowed to meet eligibility criteria)
- •Total bilirubin:=<1.5 upper limit of normal (ULN) (patients with Gilberts syndrome, total bilirubin must be <2xULN)
- •AST and ALT:=<2.5 x ULN OR =<5x ULN for patients with liver metastases
- •Creatinine =<1.5 X ULN. If creatinine is >1.5 X ULN, patient is eligible if eGFR (estimated glomerular filtration rate) is>= 30 mL/min/ 1.73 m2 (measured or calculated by CKD-EPI formula or Japanese version of CKD-EPI formula for Japanese patients)
- •Coagulation:
- •PT and aPTT:=<1.5 x ULN unless on a stable dose of an anticoagulant
- •8.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. These methods must be used during the study and for at least 6 months after the last dose of the study medication. A list of contraception methods meeting these criteria is provided in the patient information.
- •9.Patients with brain metastases are eligible provided they meet all of the following criteria:
- •- brain metastases have adequately been treated and are considered stable by the Investigator
- •- radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 765179
- •- patient is off steroids for at least 7 days (physiologic doses of steroids is permitted, if this was stable for the last 4 weeks)
- •- the patient is off anti-epileptic drugs for at least 7 days
- •Back-fill cohorts only:
- •10.Patient has agreed to and signed an informed consent (IC) form to provide mandatory pre-treatment and on-treatment fresh tumor biopsy
- •11.At least one lesion (separate from the evaluable target lesion outside of the CNS as defined per RECIST v1.1) that is accessible for mandatory paired pre and on-treatment biopsy
排除标准
- •1.Currently enrolled in another investigational device or drug trial
- •2.Previous or concomitant malignancies other than the one treated in this trial within the last 2 years except:
- •o effectively treated non-melanoma skin cancers
- •o effectively treated carcinoma in situ of the cervix
- •o effectively treated ductal carcinoma in situ
- •o other effectively treated malignancy that is considered cured by local treatment
- •3.Previous treatment with agents targeting CD137
- •4.Known leptomeningeal disease or spinal cord compression due to disease
- •5.Anticoagulant treatment that cannot be safely interrupted if medically needed (e.g., biopsy) based on the opinion of the Investigator
- •6.Persistent toxicity from previous treatments that has not resolved to =< CTCAE Grade 1 (except for alopecia, CTCAE Grade 2 neuropathy, asthenia/fatigue or grade 2 endocrinopathies controlled by replacement therapy)
- •7.Patient has a diagnosis of immunodeficiency
- •8.Patient with history of immunosuppressive medication within 14 days prior to the first dose of BI 765179. The following are exceptions to this criterion:
- •oUse of intranasal, inhaled, or topical corticosteroids, local steroid injections (e.g., intra-articular injections)
- •oSystemic corticosteroids at physiologic doses =<10 mg/day (prednisone or equivalent)
- •oPhysiological replacement dose of corticosteroids
- •9.Prior anti-cancer therapy:
- •oPatients who have been treated with any other anticancer drug within 3 weeks or within 5 half-life periods (whichever is shorter) prior to first administration of BI 765179
- •oPatients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 765179
- •10.Major injuries or surgery within the past 28 days prior to first administration of BI 765179 with incomplete wound healing, or major surgery planned during study participation, e.g. hip replacement
- •11.Patients with a previous or planned coronary revascularization (such as stent placement or heart bypass)
- •12.Any type of chronic non-healing wound/injury
- •13.Patient with active autoimmune disease or a documented history of autoimmune disease, that requires systemic treatment (i.e. corticosteroids or immunosuppressive drugs). Patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition that do not require systemic therapy, patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen may be included if in the opinion of the Investigator it is appropriate and safe to do so
- •14.Known pulmonary fibrosis
- •15.Known and documented liver cirrhosis
- •16.Known renal fibrosis
- •17.Patients requiring treatment for pleural effusion with sclerosing agents
- •18.Patients with a history of HCV infection who meet one or both of the following criteria:
- •oCurative antiviral treatment is not complete
- •oHCV viral load is above the limit of quantification (HCV RNA positive)
- •Patients on concurrent HCV therapy can participate provided that the HCV RNA is below the limit of quantification
- •19.Patients with chronic HBV infection with active disease who meet the criteria for anti HBV therapy (according to local / institutional standard) who have not been treated with suppressive antiviral therapy prior to initiation of study treatment
- •20.Patients with history of human immunodeficiency virus (HIV) infection who meet one or more of the following criteria
研究者
相似试验
已完成
不适用
An open label phase I dose finding study of BI 853520 administered orally in a continuous dosing schedule in patients with various advanced or metastatic non-hematologic malignanciessolid tumours10027655cancerNL-OMON39828Boehringer Ingelheim45
已完成
1 期
A study to find a safe and effective dose of BI 1701963 alone and in combination with BI 3011441 in patients with advanced cancer and a certain mutation (Kirsten rat sarcoma viral oncogene homologue [KRAS])KRAS mutation positive solid tumours (Parts A and B), KRAS mutation positive NSCLC and CRC (Parts CJPRN-jRCT2031200385WU HAOY124
已完成
1 期
A study to test different doses of BI 836880 combined with ezabenlimab in patients with advanced non-small cell lung cancer followed by other types of advanced solid tumoursadvanced solid tumoursJPRN-jRCT2031200207Yamagami Tomohiro6
招募中
不适用
A phase 1b, dose finding, open label study of the safety and tolerability of carboplatin-cyclophosphamide combined with atezolizumab, an antibody that targets programmed death ligand 1 (PD-L1), in patients with advanced breast cancer, ovarian, cervical and endometrial cancer.breast cancerNL-OMON45572ederlands Kanker Instituut12
进行中（未招募）
不适用
A phase Ib study to determine the maximum starting dose and to evaluate safety, pharmacokinetic and efficacy profiles of INC424 in myelofibrosis patients who have thrombocytopenia.EUCTR2010-023055-29-NLovartis Pharma Services AG62