A Study of IBI351 in Combination With Cetuximab in Subjects With KRAS G12C Mutated Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05497336
• Other study ID #: CIBI351B301
• Status: Recruiting
• Phase: Phase 1
• Start date: August 18, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2022
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: Chunxian Hu
• Phone: 0512-69566088
• Email: chunxian.hu[@]innoventbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 30, 2024
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• IBI351
IBI351 is administered orally
• Cetuximab
Cetuximab is administered intravenously

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of DLTs (Dose-limiting Toxicity) in the Combined Dose Escalation Phase		28 days during the first 4-week cycle
Primary	Objective response rate (ORR)		Up to 1 year
Secondary	incidence of serious treatment-emergent AEs (TEAEs) , treatment-related adverse event(TRAE), adverse events (SAEs)		up to 30 days after the last administration
Secondary	Number of participants with abnormality in vital signs		up to 30 days after the last administration
Secondary	Number of participants with abnormality in hematology parameters		up to 30 days after the last administration
Secondary	Number of participants with abnormality in clinical chemistry parameters		up to 30 days after the last administration
Secondary	Number of participants with abnormality in routine urinalysis parameters		up to 30 days after the last administration
Secondary	Number of participants with abnormality in ECG parameters		up to 30 days after the last administration