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

Phase 1

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Drug: IBI351; Drug: Cetuximab

• Registration Number: NCT05497336
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-11
• Study Start: 2022-08-18
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-09-30
• Primary Completion: 2023-08-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IBI351+Cetuximab	IBI351	IBI351 recommended dose+Cetuximab 500mg/m2 IV Q2W
IBI351	IBI351	IBI351 recommended dose
IBI351+Cetuximab	Cetuximab	IBI351 recommended dose+Cetuximab 500mg/m2 IV Q2W

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	Up to 1 year
Incidence of DLTs (Dose-limiting Toxicity) in the Combined Dose Escalation Phase	28 days during the first 4-week cycle

Secondary Outcome Measures

Name	Time	Method
Number of participants with abnormality in vital signs	up to 30 days after the last administration
Number of participants with abnormality in hematology 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
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 clinical chemistry parameters	up to 30 days after the last administration
Number of participants with abnormality in ECG parameters	up to 30 days after the last administration

Trial Locations

Locations (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China