Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Institut de Recherches Internationales Servier
With
ADIR, a Servier Group company
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 months
Estimated life expectancy ≥ 12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate haematological, renal and hepatic function
You may not be if
Pregnancy, possibility of becoming pregnant during the study, breastfeeding woman
Patients currently receiving or having received anticancer therapies within 4 weeks prior to the inclusion visit (Safety Lead-in part) or randomization visit (Phase 3 part).
Major surgery within 4 weeks prior to the inclusion visit (Safety Lead-in part) or randomization visit (Phase 3 part) 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 Grade \> 1 from prior anti-EGFR at the time of inclusion (Safety Lead-in part) or randomization (Phase 3 part), or any other skin toxicity precluding participation in the study according to investigator's discretion.
Treatment with systemic immunosuppressive therapy within 4 weeks prior to inclusion (Safety Lead-in part) or randomization (Phase 3 part)
Prior radiotherapy if completed less than 4 weeks before the inclusion visit (Safety Lead-in part) or randomization visit (Phase 3 part)
