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Clinical trial’s patient recruitment status
Phase of the clinical trial that is recruiting (I, II, or III)
A flag to indicate whether the trial is an immunotherapy trial
Prior Immunotherapy Allowed
Whether the clinical trial is open to patients who have received prior immunotherapy
A flag to indicate whether the trial is specifically targeting colon cancer, rectal cancer, or colorectal cancer patients
Therapeutics used in the clinical trial
Phase 3. Only for patients with KRAS/ NRAS and BRAF Wild type mCRC, who already had 2 lines of systemic chemotherapy, and and anti EGFR. Patients receive 3rd line therapy, trifluridine/tipiracil (Lonsurf) plus Futuximab/modotuximab, and anti-EGFR/HER1 therapeutic antibody, with the aim to overcome acquired resistance to anti EGFRs.
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
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 ID number from clinicaltrials.gov or other database
Date Trial Added
Date on which the clinical trial was added to the clinicaltrials.gov website
Date on which the clinical trial was updated on the clinicaltrials.gov website
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