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

Servier

Status and phase: Terminated; Phase 3

Conditions: Metastatic Colorectal Cancer

Treatments: Biological: Futuximab/modotuximab; Drug: Trifluridine/Tipiracil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05223673

2021-003151-41 (EudraCT Number)

CL3-95026-001

Details and patient eligibility

About

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).

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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)
• Patients with other malignancies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

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

Experimental group

Treatment:

Drug: Trifluridine/Tipiracil

Biological: Futuximab/modotuximab

Drug: Trifluridine/Tipiracil

Trifluridine/tipiracil (Phase III part)

Active Comparator group

Treatment:

Drug: Trifluridine/Tipiracil

Drug: Trifluridine/Tipiracil