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Terminated
NCT05497336
A Study of IBI351 in Combination With Cetuximab in Subjects With KRAS G12C Mutated Metastatic Colorectal Cancer
Conditions: Colorectal Cancer
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 8
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Location: The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang
Summary
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
Eligibility Criteria
Inclusion Criteria:
1. male or female subjects, ≥ 18 years and ≤ 75 years
2. have documentation of KRAS G12C mutation
3. at least one measurable lesion per RECISTv1.1
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
5. life expectancy of \>12 weeks, in the opinion of the investigator
Exclusion Criteria:
1. history of deep venous thrombosis or any other serious thromboembolism within 3 months prior to enrollment..
2. history of radiation-induced pneumonitis, idiopathic pneumonia, active pneumonia, pulmonary fibrosis, diffuse pulmonary interstitial disease, or organizing pneumonia.
3. surgical procedures (excluding needle biopsy) performed within 28 days prior to enrollment that may affect the dosing or study assessments in this study.
4. received therapeutic or palliative radiation therapy within 14 days prior to enrollment
5. pregnant or lactating women
Source: ClinicalTrials.gov (NCT05497336). StuddyBuddy aggregates publicly available trial information.