Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal Cancer

• Status: Not yet recruiting
• Trial end date: 2026-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized phase III study with a safety lead-in part in patients with KRAS/ NRAS and BRAF Wild Type metastatic colorectal cancer who have previously received treatment with oxaliplatin, irinotecan, fluoropyrimidines, anti-VEGF agents and anti-EGFR antibodies. . The main objective of the safety lead-in part is to assess safety and tolerability of futuximab/modotuximab in combination with trifluridine/tipiracil. The primary objective of the phase III part is to compare Overall Survival of futuximab/modotuximab in combination with trifluridine/tipiracil vs trifluridine/tipiracil monotherapy in patients with tumours that are KRAS/NRAS and BRAF wild-type (WT) (Double negative [DN].

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Recherches Internationales Servier
• Collaborator: ADIR, a Servier Group company
• Treatments: Trifluridine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 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