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Trial Title:
A Study of IBI351 in Combination With Cetuximab in Subjects With KRAS G12C Mutated Metastatic Colorectal Cancer
NCT ID:
NCT05497336
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Cetuximab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IBI351
Description:
IBI351 is administered orally
Arm group label:
IBI351
Arm group label:
IBI351+Cetuximab
Other name:
GFH925
Intervention type:
Drug
Intervention name:
Cetuximab
Description:
Cetuximab is administered intravenously
Arm group label:
IBI351+Cetuximab
Other name:
Erbitux
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Second Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xia Liu
Phone:
0571-87783759
Email:
shaorong05405@126.com
Investigator:
Last name:
Kefeng Ding, MD
Email:
Principal Investigator
Start date:
August 18, 2022
Completion date:
September 30, 2024
Lead sponsor:
Agency:
Innovent Biologics (Suzhou) Co. Ltd.
Agency class:
Industry
Source:
Innovent Biologics (Suzhou) Co. Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05497336