New drugs for the treatment of metastatic colorectal cancer

Table 1 Main ongoing studies (clinicaltrial.gov) for metastatic colorectal cancer

Study	Treatment	Phase of study	Primary objectives
COLOMATE trial
NCT03765736	Specific targeted treatment arms based on the molecular profiles	Phase II prospective trial	(1) To perform blood-based genomic profiling on patients with treatment refractory metastatic colorectal cancer (CRC) to facilitate accrual to molecularly assigned therapies; and (2) To facilitate clinically annotated genomic analyses
CALGB (Alliance)/SWOG 80405
NCT00265850	Bevacizumab or cetuximab combined with the same chemotherapy	Phase III, randomized, open-label, multicentre study	To determine if the addition of cetuximab to FOLFIRI or FOLFOX chemotherapy prolongs survival compared to FOLFIRI or FOLFOX with bevacizumab in patients with untreated, advanced or metastatic colorectal cancer who have K-ras wild type tumours
KRYSTAL 10
NCT04793958	MRTX849 (inhibitor of KRAS G12C) in Combination with Cetuximab vs Chemotherapy	Phase III, open-label, randomized	Comparing the efficacy of MRTX849 administered in combination with cetuximab vs chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation
C-PRECISE-01
NCT04495621	MEN1611 + Cetuximab	Phase Ib/II, open-label, multicentre study	MEN1611, a PI3K Inhibitor, and Cetuximab in Patients With PIK3CA Mutated Metastatic Colorectal Cancer Failing Irinotecan, Oxaliplatin, 5-FU and Anti-EGFR Containing Regimens
NCT04096417	Pemigatinib	phase II, multicentre, single-Arm study	To assess overall response rate (ORR) of pemigatinib in patients with metastatic or unresectable CRC harbouring activating FGFR alterations
MOUNTAINEER
NCT03043313	Trastuzumab+tucatinib	Phase II open label study	Tucatinib combined with trastuzumab in patients with HER2+ metastatic colorectal cancer
NAVIGATE
NCT02576431	Larotrectinib	Phase II open label study	Investigate the efficacy of larotrectinib for the treatment of advanced solid tumours harbouring a fusion of neurotrophic tyrosine receptor kinase (NTRK) of types 1–3 in children and adults
NCT03829410	Onvansertib (PCM-075)	Phase Ib/II open label study	Determine the safety and efficacy of Onvansertib in combination with FOLFIRI + Avastin, as second-line treatment in adult patients who have metastatic colorectal cancer with a Kras mutation
STARTRK-2
NCT02568267	Entrectinib (RXDX-101)	Phase 2 basket study	Treatment of patients with Locally Advanced or metastatic solid tumours that harbour NTRK1/2/3, ROS1, or ALK gene rearrangements
NCT03724851	Vactosertib (TGF-β receptor I kinase inhibitor) + pembrolizumab	Phase 2, open label study	Safety, tolerability, pharmacokinetics and antitumour activity of vactosertib in combination with pembrolizumab in patients with mCRC including CMS4 or diffuse GC/GEJC

EGFR: Epidermal growth factor receptor; TGF-β: Transforming growth factor-β.