A randomised, open-label, multi-centre, two-arm Phase 3 study comparing futuximab/modotuximab in combination with trifluridine/tipiracil to trifluridine/tipiracil single agent with a Safety Lead-In part in participants with KRAS/NRAS and BRAF wild type metastatic colorectal cancer previously treated with standard treatment and anti-EGFR therapy - COLSTAR

Martin Lourdes0 个研究点目标入组 500 人开始时间: 2022年3月9日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Histologically or cytologically confirmed adenocarcinoma of metastatic colorectal cancer (mCRC), not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumour without RAS (KRAS and NRAS) and BRAF V600E mutations based on Circulating tumour DNA (ctDNA) screening blood test analysis
•-Participants with measurable or non-measurable lesion
•-Participants must have received at least 2 prior regimens of standard chemotherapy for mCRC and had demonstrated progressive disease or intolerance to their last regimen
•-Participants should have received previous treatment with commercially available anti-EGFR mAbs for 4 or more months
•-Estimated life expectancy 12 or more weeks
•-Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
•-Adequate haematological, renal and hepatic function

•-Pregnancy, possibility of becoming pregnant during the study, breastfeeding woman
•-Patients currently receiving or having received anticancer therapies within 4 weeks prior to first IMP administration
•-Major surgery within 4 weeks prior to the first IMP administration or participants who have not recovered from side effects of the surgery
•-Participants with serious/active/uncontrolled infection
•-Known clinically significant cardiovascular disease or condition
•-Significant gastrointestinal abnormality
•-Skin rash of more than Grade 1 from prior anti-EGFR
•-Treatment with systemic immunosuppressive therapy
•-Prior radiotherapy if completed less than 4 weeks before first IMP administration
•-Patients with other malignancies

发起方

Martin Lourdes