CTIS2024-515446-16-00进行中（未招募）1 期
AN OPEN-LABEL, SINGLE-ARM, PHASE IB/IIA TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF THE EP4 RECEPTOR ANTAGONIST CR6086 IN COMBINATION WITH THE PD-1 INHIBITOR BALSTILIMAB (AGEN2034), IN PATIENTS WITH PRETREATED MISMATCH-REPAIR-PROFICIENT AND MICROSATELLITE STABLE METASTATIC COLORECTAL CANCER, AND OTHER METASTATIC GI CANCERS - CR6086-1-04
Rottapharm Biotech S.r.l.0 个研究点目标入组 55 人开始时间: 2024年6月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •Main Study: Signed and dated informed consent obtained before undergoing any study-specific procedure, Eastern Cooperative Oncology Group (ECOG) performance status of = 1, Anticipated life expectancy = 3 months, Adequate hematologic and end organ function, defined by the following laboratory results, obtained within 7 days before first dose of study drug treatment: 1. Hemoglobin = 10 g/dL, platelet count =100,000/mm3, ANC =1500/mm3 2. Creatinine clearance = 50 mL/min 3. Amylase and lipase = 1.5 × ULN 4. Serum bilirubin = 1.5× ULN 5. AST, ALT, and ALP = 2.5 × ULN with the following exceptions: - Patients with documented liver metastases: AST and/or ALT = 5 × ULN 6. INR and PTT = 1.5 × ULN. - Patients who are on therapeutic doses of anti-coagulants should be on a stable dose for 28 days, with stable INR and PTT values. 7. Serum albumin = 3.0 g/dL, Ability e and willingness to participate and comply with the requirements of the entire study, Study Extension_Cohort A and B: Signed and dated informed consent obtained before undergoing any study-specific procedure, Male or female aged =18 years, Body weight > 40kg, Histologically proven advanced-stage unresectable adenocarcinoma of the stomach or the GEJ, Stage IV (according to the American Joint Committee on Cancer definition), Available CPS or available tissue to perform CPS assessment: Cohort A: CPS=5 - Cohort B CPS<5, Male or female aged =18 years, Failure to at least one prior line of chemotherapy for metastatic disease, given with or without trastuzumab, with or without anti-PD-1. In alternative, early disease recurrence after surgery with neo-adjuvant and/or adjuvant chemotherapy (within 6 months of the last administration of chemotherapy) or progression during neo-adjuvant and/or adjuvant chemotherapy (containing fluoropyrimidine and a platinum derivative)., Presence of measurable disease per RECIST v1.1 (based on imaging within 28 days from first study drug administration). Patients must have at least one target lesion to be used to assess response, as defined by RECIST v1.1, Naïve to EP4 receptor antagonists, Availability of adequate and sufficient baseline tumour tissue sample (archival or newly obtained biopsy), Eastern Cooperative Oncology Group (ECOG) performance status of = 1, Anticipated life expectancy = 3 months, Adequate hematologic and end organ function, defined by the following laboratory results, obtained within 7 days before first dose of study drug treatment: 1. Hemoglobin = 10 g/dL, platelet count =100,000/mm3, ANC =1500/mm3 2. Creatinine clearance = 50 mL/min 3. Amylase and lipase = 1.5 × ULN 4. Serum bilirubin = 1.5× ULN 5. AST, ALT, and ALP = 2.5 × ULN with the following exceptions: - Patients with documented liver metastases: AST and/or ALT = 5 × ULN 6. INR and PTT = 1.5 × ULN. - Patients who are on therapeutic doses of anti-coagulants should be on a stable dose for 28 days, with stable INR and PTT values. 7. Serum albumin = 3.0 g/dL, Ability e and willingness to participate and comply with the requirements of the entire study, Study Extension_Cohort C: Signed and dated informed consent obtained before undergoing any study-specific procedure, Male or female aged =18 years, Histologically confirmed diagnosis of adenocarcinoma originating from the colon or rectum, with known RAS and BRAF mutational status as assessed per standard practice, Body weight > 40kg, Histologically proven advanced-stage unresectable GI cancer other than CRC and GC, Stage IV (according to
排除标准
- •Main and Extension Study: Additional malignancy that progressed or required active treatment within the last 2 years. Exceptions include basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin that has undergone potentially curative therapy with no evidence of recurrence for 5 years since initiation of that curative therapy, or carcinoma in situ (breast carcinoma, cervical cancer), History of stroke, reversible ischemic neurological defect, or transient ischemic attack within 6 months before enrolment, Uncontrolled ventricular arrhythmia, Congestive heart failure (New York Hearth Association class =II), Poorly controlled hypertension, Confirmed infection with SARS-CoV-2 as documented by molecular testing at nasopharyngeal swab, HIV infection, Active tuberculosis, Acute or chronic viral hepatitis B or C infection, Any severe infection within 14 days before Cycle 1 Day 1, Active autoimmune disease in the past 2 years, Active brain tumour, metastasis or leptomeningeal metastases. Patients with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI except where contraindicated in which CT scan is acceptable) evidence of progression for at least 8 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. Cases should be discussed with the Sponsor. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (>10mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration, History of allogenic tissue/solid organ transplant (including allogeneic bone marrow transplantation), History of immunodeficiency, History or presence of interstitial lung disease or history of pneumonitis that has required oral or iv corticosteroids., History of gastric/duodenal ulcers, colitis and/or gastrointestinal bleeding, History of severe gastrointestinal adverse reactions, History of hypersensitivity reactions to fully human monoclonal antibodies, Grade = 3 according to NCI CTCAE Version 5.0, History of anaphylaxis, or uncontrolled asthma, Allergy/hypersensitivity/intolerance to any component of CR6086 or AGEN2034, Any other clinically relevant disease and condition, including psychiatric or substance abuse disorders, that, in the opinion of the Investigator, may jeopardize efficacy or safety assessments, confound the result of the trial or may compromise the patient’s safety during trial participation, Administration of a live, attenuated vaccine within 28 days before Cycle 1 D1, Major surgery within 28 days before Cycle 1 Day 1 or anticipation of needing such procedure during the trial, Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before screening, Regular use of any illicit drugs or recent history (within the last year) of substance abuse (including alcohol), Participation in a study with an investigational drug or medical device within 28 days before Cycle 1 Day 1, Inability to swallow medications, Malabsorption conditions, For women of childbearing potential: ? Pregnancy (i.e. positive pregnancy test at Screening) or breastfeeding ? Failure to agree to practice a highly effective method of contraception (see Section 12.4), from enrolment up to at least 120 days after the last IMP intake ? expecting to conceive within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of stud
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