To hear about similar clinical trials, please enter your email below

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

Login to your account

Did you forget your password?