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

August 17, 2026 updated by: Innovent Biologics (Suzhou) Co. Ltd.

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • The Second Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IBI351+Cetuximab
IBI351 recommended dose+Cetuximab 500mg/m2 IV Q2W
Drug: IBI351
IBI351 is administered orally
Other Names:
  • GFH925
Drug: Cetuximab
Cetuximab is administered intravenously
Other Names:
  • Erbitux
Experimental: IBI351
IBI351 recommended dose
Drug: IBI351
IBI351 is administered orally
Other Names:
  • GFH925

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
up to 30 days after the last administration
Number of participants with abnormality in vital signs
Time Frame: up to 30 days after the last administration
up to 30 days after the last administration
Number of participants with abnormality in hematology parameters
Time Frame: up to 30 days after the last administration
up to 30 days after the last administration
Number of participants with abnormality in clinical chemistry parameters
Time Frame: up to 30 days after the last administration
up to 30 days after the last administration
Number of participants with abnormality in routine urinalysis parameters
Time Frame: up to 30 days after the last administration
up to 30 days after the last administration
Number of participants with abnormality in ECG parameters
Time Frame: up to 30 days after the last administration
up to 30 days after the last administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2022

Primary Completion (Actual)

January 24, 2025

Study Completion (Actual)

January 24, 2025

Study Registration Dates

First Submitted

August 9, 2022

First Submitted That Met QC Criteria

August 9, 2022

First Posted (Actual)

August 11, 2022

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBI351B301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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