Targeting SHP2: Dual breakthroughs in colorectal cancer therapy–from signaling pathway modulation to immune microenvironment remodeling

doi:10.4251/wjgo.v17.i7.107380

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World Journal of Gastrointestinal Oncology

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World J Gastrointest Oncol. Jul 15, 2025; 17(7): 107380
Published online Jul 15, 2025. doi: 10.4251/wjgo.v17.i7.107380

Table 1 Clinical trials targeting SHP2

Trial name (NCT number)	Phase	Combination/therapeutic strategy	Target indication	Key populations/findings	Status/updates
NCT03634982	Phase 1	RMC-4630	Advanced solid tumors (including CRC)	Monotherapy	Active
NCT04121286	Phase 1	JAB-3312	Advanced solid tumors (including CRC)	Monotherapy	Recruiting
NCT03518554*	Phase 1	JAB-3068	Advanced solid tumors (including CRC)	Monotherapy	Complete
NCT03565003	Phase 1/2	JAB-3068	Advanced solid tumors (including CRC)	Monotherapy	Complete
NCT05354843	Phase 1	ET0038	Advanced solid tumors (including CRC)	Monotherapy	Recruiting
NCT04528836	Phase 1	BBP-398	Advanced solid tumors (including CRC)	Monotherapy	Terminated in 2024
NCT03114319	Phase 1	TNO155 + nazartinib	Advanced EGFR/KRAS-mutant solid tumors	Monotherapy or combination use with EGFR TKIs	Active
NCT04330664	Phase 1	TNO155 + MRTX849	Advanced solid tumors with KRAS^G12C mutation	Combination therapy	Complete
NCT04294160	Phase 1	Dabrafenib + LTT462 + TNO155 Dabrafenib + trametinib + TNO155	Advanced or metastatic BRAF^V600E-mutated CRC	Combination therapy	Terminated in 2024
NCT04000529	Phase 1	TNO155 + spartalizumab/ribociclib	Selected malignancies	Monotherapy or combination of TNO155 with spartalizumab or with ribociclib	Terminated in 2024
NCT04699188	Phase 1/2	JDQ443 + TNO155 + tislelizumab	KRAS^G12C-mutant NSCLC, CRC	Monotherapy or with KRAS^G12C inhibitor, Dose Escalation Study	Active
NCT04916236	Phase 1	RMC-4630 + LY3214996	Metastatic KRAS-mutant CRC, PDAC, and NSCLC	Combination therapy of RMC-4630 (SHP2 inhibitor) and LY3214996 (ERK inhibitor)	Terminated in 2024
NCT04185883	Phase 1	Sotorasib + RMC-4630	KRAS^G12C mutant advanced solid tumors	Combination therapy	Recruiting
NCT04670679	Phase 1	ERAS-601 + cetuximab/pembrolizumab	Advanced solid tumors (including CRC)	Monotherapy or combination treatment with cetuximab/pembrolizumab	Active
NCT04252339	Phase 1	RLY-1971	Advanced or metastatic solid tumors	Monotherapy, dose escalation, and expansion study	Complete

NCT: National clinical trial; CRC: Colorectal cancer.

Citation: Liu P, Chen J. Targeting SHP2: Dual breakthroughs in colorectal cancer therapy–from signaling pathway modulation to immune microenvironment remodeling. World J Gastrointest Oncol 2025; 17(7): 107380
URL: https://www.wjgnet.com/1948-5204/full/v17/i7/107380.htm
DOI: https://dx.doi.org/10.4251/wjgo.v17.i7.107380