A Study of IBI351 in Combination With Cetuximab in Subjects With KRAS G12C Mutated Metastatic Colorectal Cancer
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Key facts
- Where
- Hangzhou, KínaSee the site
- Phase
- 1. fázis
Where in Kína
- The Second Affiliated Hospital of Zhejiang University School of MedicineHangzhou, KínaNo longer taking part
Trial details
- Who runs it
- Innovent Biologics (Suzhou) Co. Ltd.
- Trial code
- NCT05497336
- Record updated
- 2026. augusztus 19.
- Original description
Phase 1b consists of combined dose escalation phase and dose expansion phase. Phase 3 study will compare efficacy and safety of IBI351 combined with cetuximab versus chemotherapy in treatment of KRAS G12C-mutated metastatic colorectal cancerRead full original descriptionShow less
An Open-label, Multicenter, Phase Ib/III Study of Efficacy and Safety of IBI351 in Combination With Cetuximab in Subjects With KRAS G12C Mutated Metastatic Colorectal Cancer
Phase 1b consists of combined dose escalation phase and dose expansion phase. Phase 3 study will compare efficacy and safety of IBI351 combined with cetuximab versus chemotherapy in treatment of KRAS G12C-mutated metastatic colorectal cancer
Inclusion: male or female subjects, ≥ 18 years and ≤ 75 years; have documentation of KRAS G12C mutation; at least one measurable lesion per RECISTv1.1; Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1; life expectancy of >12 weeks, in the opinion of the investigator.
Exclusion: history of deep venous thrombosis or any other serious thromboembolism within 3 months prior to enrollment; surgical procedures (excluding needle biopsy) performed within 28 days prior to enrollment that may affect the dosing or study assessments in this study; received therapeutic or palliative radiation therapy within 14 days prior to enrollment; history of radiation-induced pneumonitis, idiopathic pneumonia, active pneumonia, pulmonary fibrosis, diffuse pulmonary interstitial disease, or organizing pneumonia; pregnant or lactating women.