OncoMatch/Clinical Trials/NCT07361003
A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer
Is NCT07361003 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Suvemcitug for refractory metastatic colorectal cancer.
Treatment: Suvemcitug — The primary goal of Phase Ib Study is to evaluate the safety of Suvemcitug in combination with trifluridine/tipiracil tablets in colorectal cancer participants. The primary goal of Phase III Study is to evaluate the efficacy of Suvemcitug in combination with trifluridine/tipiracil tablets in colorectal cancer participants. Researchers will compare Suvemcitug + trifluridine/tipiracil tablets with placebo (a look-alike substance that contains no drug)+ trifluridine/tipiracil tablets to see if Suvemcitug + trifluridine/tipiracil tablets works better in treating refractory metastatic colorectal cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Allowed: KRAS mutation
RAS mutation status confirmed by testing tumor tissue and /or blood sample
Allowed: NRAS mutation
RAS mutation status confirmed by testing tumor tissue and /or blood sample
Allowed: KRAS wild-type
For participants with RAS wild-type, had previously undergone or was unsuitable for anti-EGFR therapy
Allowed: NRAS wild-type
For participants with RAS wild-type, had previously undergone or was unsuitable for anti-EGFR therapy
Disease stage
Metastatic disease required
Prior therapy
Must have received: fluorouracil-based chemotherapy
Previously received fluorouracil...based chemotherapy
Must have received: oxaliplatin-based chemotherapy
Previously received...oxaliplatin...based chemotherapy
Must have received: irinotecan-based chemotherapy
Previously received...irinotecan based chemotherapy
Must have received: anti-VEGF therapy
had previously undergone or was unsuitable for anti-VEGF therapy
Must have received: anti-EGFR therapy
For participants with RAS wild-type, had previously undergone or was unsuitable for anti-EGFR therapy
Lab requirements
Blood counts
good organ and bone marrow function (no administration of hematopoietic growth factors, blood transfusion, or platelets within 14 days before screening hematology test)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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