A study of futuximab/modotuximab in combination with trifluridine/tipiracil in participants with previously treated colorectal cancer that has spread (metastatic)

JRCT ID: jRCT2031210653

Registered date:09/03/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Metastatic Colorectal Cancer
• Date of first enrollment: 21/04/2022
• Target sample size: 500
• Countries of recruitment: Belgium,Japan,Denmark,Japan,Finland,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Experimental: Futuximab/modotuximab combined with trifluridine/tipiracil (Safety Lead-In and Phase III parts)

Biological: Futuximab/modotuximab
Concentrate for solution for infusion, futuximab/modotuximab will be administered via IV route, once weekly of each cycle at 9 mg/kg/dose at Cycle 1 Day 1 and then at 6 mg/kg/dose. Each cycle is up to 28 days.

Drug: Trifluridine/Tipiracil
Film-coated tablets of trifluridine/tipiracil (35 mg/m2/dose) will be administered orally before futuximab/ modotuximab administration, twice a day (BID) within 1 hour after completion of morning and evening meals, 5 days on/2 days off, over 14 days, followed by a 14-day rest. This treatment cycle will be repeated every 28 days.

Active Comparator: Trifluridine/tipiracil (Phase III part)

Drug: Trifluridine/Tipiracil
Film-coated tablets of trifluridine/tipiracil (35 mg/m2/dose) will be administered orally twice a day (BID) within 1 hour after completion of morning and evening meals, 5 days on/2 days off, over 14 days, followed by a 14-day rest. This treatment cycle will be repeated every 28 days.

Outcome(s)

Primary Outcome

Incidence of dose-limiting toxicities (DLTs) (Safety Lead-In part) [ Time Frame: End of cycle 1 (Each cycle is up to 28 days) ]
DLTs observed during a 28-day period

Overall Survival (OS) (In double negative, KRAS/NRAS and BRAF wild type patients) (Phase III part) [ Time Frame: up to 4 years 9 months ]
Time elapsed from date of randomization until the date of death from any cause

Secondary Outcome

Overall survival (Safety Lead-In part) [ Time Frame: up to 24 months ]
Time elapsed from the first IMP intake to death

Overall survival (In triple negative) (Phase III part) [ Time Frame: up to 4 years 9 months ]
Time elapsed from the date of randomization into the study to disease progression/death

Progression Free Survival (Phase III part) [ Time Frame: up to 4 years 9 months ]
Time elapsed from the date of randomization into the study to disease progression/death

Adverse Events (Phase III part) [ Time Frame: Through study completion, up to 4 years 9 months ]
Incidence, severity, and relationship of treatment emergent adverse event and treatment emergent serious adverse event

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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 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

Exclude 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 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

Related Information

• Primary Sponsor: Martin Lourdes
• Secondary ID(s): NCT05223673