Back to resultsA Study of IBI351 in Combination With Cetuximab in Subjects With KRAS G12C Mutated Metastatic Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IBI351
Cetuximab
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- history of deep venous thrombosis or any other serious thromboembolism within 3 months prior to enrollment..
- history of radiation-induced pneumonitis, idiopathic pneumonia, active pneumonia, pulmonary fibrosis, diffuse pulmonary interstitial disease, or organizing pneumonia.
- 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
- pregnant or lactating women
Sites / Locations
- The Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
IBI351+Cetuximab
IBI351
Arm Description
IBI351 recommended dose+Cetuximab 500mg/m2 IV Q2W
IBI351 recommended dose
Outcomes
Primary Outcome Measures
Incidence of DLTs (Dose-limiting Toxicity) in the Combined Dose Escalation Phase
Objective response rate (ORR)
Secondary Outcome Measures
incidence of serious treatment-emergent AEs (TEAEs) , treatment-related adverse event(TRAE), adverse events (SAEs)
Number of participants with abnormality in vital signs
Number of participants with abnormality in hematology parameters
Number of participants with abnormality in clinical chemistry parameters
Number of participants with abnormality in routine urinalysis parameters
Number of participants with abnormality in ECG parameters
Full Information
NCT ID
NCT05497336
First Posted
August 9, 2022
Last Updated
September 28, 2022
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05497336
Brief Title
A Study of IBI351 in Combination With Cetuximab in Subjects With KRAS G12C Mutated Metastatic Colorectal Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2022 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IBI351+Cetuximab
Arm Type
Experimental
Arm Description
IBI351 recommended dose+Cetuximab 500mg/m2 IV Q2W
Arm Title
IBI351
Arm Type
Experimental
Arm Description
IBI351 recommended dose
Intervention Type
Drug
Intervention Name(s)
IBI351
Other Intervention Name(s)
GFH925
Intervention Description
IBI351 is administered orally
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
Cetuximab is administered intravenously
Primary Outcome Measure Information:
Title
Incidence of DLTs (Dose-limiting Toxicity) in the Combined Dose Escalation Phase
Time Frame
28 days during the first 4-week cycle
Title
Objective response rate (ORR)
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
incidence of serious treatment-emergent AEs (TEAEs) , treatment-related adverse event(TRAE), adverse events (SAEs)
Time Frame
up to 30 days after the last administration
Title
Number of participants with abnormality in vital signs
Time Frame
up to 30 days after the last administration
Title
Number of participants with abnormality in hematology parameters
Time Frame
up to 30 days after the last administration
Title
Number of participants with abnormality in clinical chemistry parameters
Time Frame
up to 30 days after the last administration
Title
Number of participants with abnormality in routine urinalysis parameters
Time Frame
up to 30 days after the last administration
Title
Number of participants with abnormality in ECG parameters
Time Frame
up to 30 days after the last administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
history of deep venous thrombosis or any other serious thromboembolism within 3 months prior to enrollment..
history of radiation-induced pneumonitis, idiopathic pneumonia, active pneumonia, pulmonary fibrosis, diffuse pulmonary interstitial disease, or organizing pneumonia.
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
pregnant or lactating women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunxian Hu
Phone
0512-69566088
Email
chunxian.hu@innoventbio.com
Facility Information:
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xia Liu
Phone
0571-87783759
Email
shaorong05405@126.com
First Name & Middle Initial & Last Name & Degree
Kefeng Ding, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of IBI351 in Combination With Cetuximab in Subjects With KRAS G12C Mutated Metastatic Colorectal Cancer
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