OncoMatch/Clinical Trials/NCT07314294
Phase II Study of EMB-01 in Recurrent/Metastatic Colorectal Cancer Patients
Is NCT07314294 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including EMB-01 1600 mg administered once weekly throughout the study and EMB-01 1600 mg once weekly for 6 weeks, then every 2 weeks thereafter for metastatic colorectal cancer.
Treatment: EMB-01 1600 mg administered once weekly throughout the study · EMB-01 1600 mg once weekly for 6 weeks, then every 2 weeks thereafter — This study is testing different dosing schedules of EMB-01 in patients with advanced colorectal cancer whose disease has recurrent or progressed on previous treatments. Patients will be randomly assigned to one of two dosing schedules: EMB-01 once weekly, or once weekly for 6 weeks then every two weeks.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS exon 2 mutation
Presence of KRAS/NRAS exon 2, 3, 4 mutations ... based on central lab testing or prior treatment history
Required: KRAS exon 3 mutation
Presence of KRAS/NRAS exon 2, 3, 4 mutations ... based on central lab testing or prior treatment history
Required: KRAS exon 4 mutation
Presence of KRAS/NRAS exon 2, 3, 4 mutations ... based on central lab testing or prior treatment history
Required: NRAS exon 2 mutation
Presence of KRAS/NRAS exon 2, 3, 4 mutations ... based on central lab testing or prior treatment history
Required: NRAS exon 3 mutation
Presence of KRAS/NRAS exon 2, 3, 4 mutations ... based on central lab testing or prior treatment history
Required: NRAS exon 4 mutation
Presence of KRAS/NRAS exon 2, 3, 4 mutations ... based on central lab testing or prior treatment history
Required: BRAF V600 mutation
Presence of ... BRAF V600 mutation ... based on central lab testing or prior treatment history
Required: HER2 (ERBB2) positivity (IHC3+ or amplification) (IHC3+ or amplification)
Presence of ... HER2 positivity (IHC3+ or amplification) ... based on central lab testing or prior treatment history
Required: RET fusion
Presence of ... RET fusion ... based on central lab testing or prior treatment history
Required: NTRK1 fusion
Presence of ... NTRK fusion ... based on central lab testing or prior treatment history
Required: NTRK2 fusion
Presence of ... NTRK fusion ... based on central lab testing or prior treatment history
Required: NTRK3 fusion
Presence of ... NTRK fusion ... based on central lab testing or prior treatment history
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: fluoropyrimidine — metastatic
Prior therapy must include fluoropyrimidine
Must have received: oxaliplatin — metastatic
Prior therapy must include oxaliplatin
Must have received: irinotecan-based chemotherapy — metastatic
Prior therapy must include irinotecan-based chemotherapy
Must have received: VEGF inhibitor (bevacizumab) — metastatic
Prior therapy must include ... bevacizumab
Cannot have received: TAS-102 (TAS-102)
Patients should not have received TAS-102
Cannot have received: fruquintinib (fruquintinib)
Patients should not have received ... fruquintinib
Cannot have received: regorafenib (regorafenib)
Patients should not have received ... regorafenib
Cannot have received: dual anti-EGFR and cMET therapy
Prior dual anti-EGFR and cMET therapy or bispecific antibody-drug conjugates (ADCs)
Cannot have received: bispecific antibody-drug conjugate
Prior dual anti-EGFR and cMET therapy or bispecific antibody-drug conjugates (ADCs)
Cannot have received: EGFR inhibitor
Exception: if discontinued due to severe skin toxicity
Prior EGFR inhibitor therapy discontinued due to severe skin toxicity
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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