Colorectal Cancer
Conditions
Brief 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
Detailed description
A Phase 1b study of the safety, tolerability and preliminary efficacy of IBI351 combined with cetuximab in the treatment of KRAS G12C mutant metastatic colorectal cancer will be conducted based on recommended dose of IBI351, which consists of combined dose escalation phase and dose expansion phase. After confirming the efficacy and safety of IBI351 combined with cetuximab in Phase Ib, an open-label Phase 3 study of the efficacy and safety of IBI351 combined with cetuximab versus oxaliplatin-based mFOLFOX6 regimen or irinotecan-based FOLFIRI with or without bevacizumab in treatment of KRAS G12C-mutated metastatic colorectal cancer will be conducted.
Interventions
DRUGIBI351
IBI351 is administered orally
DRUGCetuximab
Cetuximab is administered intravenously
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of DLTs (Dose-limiting Toxicity) in the Combined Dose Escalation Phase | 28 days during the first 4-week cycle |
| Objective response rate (ORR) | Up to 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with abnormality in hematology parameters | up to 30 days after the last administration |
| Number of participants with abnormality in clinical chemistry parameters | up to 30 days after the last administration |
| incidence of serious treatment-emergent AEs (TEAEs) , treatment-related adverse event(TRAE), adverse events (SAEs) | up to 30 days after the last administration |
| Number of participants with abnormality in ECG parameters | up to 30 days after the last administration |
| Number of participants with abnormality in routine urinalysis parameters | up to 30 days after the last administration |
| Number of participants with abnormality in vital signs | up to 30 days after the last administration |
Countries
China
Contacts
Primary ContactChunxian Hu
Outcome results
None listed