A study of futuximab/modotuximab in combination with trifluridine/tipiracil in participants with previously treated colorectal cancer that has spread (metastatic)
- Conditions
- Metastatic Colorectal Cancer
- Registration Number
- JPRN-jRCT2031210653
- Lead Sponsor
- Martin Lourdes
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of dose-limiting toxicities (DLTs) (Safety Lead-In part) [ Time Frame: End of cycle 1 (Each cycle is up to 28 days) ]<br>DLTs observed during a 28-day period<br><br>Overall Survival (OS) (In double negative, KRAS/NRAS and BRAF wild type patients) (Phase III part) [ Time Frame: up to 4 years 9 months ]<br>Time elapsed from date of randomization until the date of death from any cause
- Secondary Outcome Measures
Name Time Method Overall survival (Safety Lead-In part) [ Time Frame: up to 24 months ]<br>Time elapsed from the first IMP intake to death<br><br>Overall survival (In triple negative) (Phase III part) [ Time Frame: up to 4 years 9 months ]<br>Time elapsed from the date of randomization into the study to disease progression/death<br><br>Progression Free Survival (Phase III part) [ Time Frame: up to 4 years 9 months ]<br>Time elapsed from the date of randomization into the study to disease progression/death<br><br>Adverse Events (Phase III part) [ Time Frame: Through study completion, up to 4 years 9 months ]<br>Incidence, severity, and relationship of treatment emergent adverse event and treatment emergent serious adverse event