Colorectal CancerPhase 1NCT05497336
A Study of IBI351 in Combination With Cetuximab in Subjects With KRAS G12C Mutated Metastatic Colorectal Cancer
A Phase 1 study testing IBI351 and Cetuximab in people with Colorectal Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- IBI351 and Cetuximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2022to 24 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
About this study
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
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
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- IBI351, Cetuximab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI351Drug
Also called GFH925
IBI351 is administered orally
CetuximabDrug
Also called Erbitux
Cetuximab is administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| IBI351+Cetuximab | Experimental | IBI351 recommended dose+Cetuximab 500mg/m2 IV Q2W Receives: Drug: IBI351; Drug: Cetuximab |
| IBI351 | Experimental | IBI351 recommended dose Receives: Drug: IBI351 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLTs (Dose-limiting Toxicity) in the Combined Dose Escalation Phase
Measured: 28 days during the first 4-week cycle
Objective response rate (ORR)
Measured: Up to 1 year
Secondary outcomes (6)
incidence of serious treatment-emergent AEs (TEAEs) , treatment-related adverse event(TRAE), adverse events (SAEs)
Measured: up to 30 days after the last administration
Number of participants with abnormality in vital signs
Measured: up to 30 days after the last administration
Number of participants with abnormality in hematology parameters
Measured: up to 30 days after the last administration
Number of participants with abnormality in clinical chemistry parameters
Measured: up to 30 days after the last administration
Number of participants with abnormality in routine urinalysis parameters
Measured: up to 30 days after the last administration
Number of participants with abnormality in ECG parameters
Measured: up to 30 days after the last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start18 Aug 2022
- Primary completion24 Jan 2025
- Study completion24 Jan 2025
Why it stopped: company development strategy adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497336
- Sponsor's protocol ID
- CIBI351B301
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2022
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yuan Y, Deng Y, Jin Y, Guo Z, Pan Y, Wang C, Wang Z, Hu Y, Hua D, Meng X, Zhang Z, Zhao M, Dong X, Huang D, Li X, Liu L, Sun M, Wang H, Wang X, Yang N, Zhang M, Hu S, Wu D, Huang J, Zhang S, Huang M, Ding K. Efficacy and safety of IBI351 (fulzerasib) monotherapy in KRASG12C inhibitor-naive Chinese patients with KRASG12C-mutated metastatic colorectal cancer: a pooled analysis from phase I part of two studies. Signal Transduct Target Ther. 2025 Jul 25;10(1):241. doi: 10.1038/s41392-025-02315-7.
PubMed 40715048
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05497336
- Acronym / sponsor ID
- CIBI351B301
- Conditions
- Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: company development strategy adjustment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBI351+Cetuximab | Experimental | Drug: IBI351, Drug: CetuximabIBI351 recommended dose+Cetuximab 500mg/m2 IV Q2W |
| IBI351 | Experimental | Drug: IBI351IBI351 recommended dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI351Also: GFH925IBI351 is administered orally | Drug | IBI351, IBI351+Cetuximab |
| CetuximabAlso: ErbituxCetuximab is administered intravenously | Drug | IBI351+Cetuximab |
Primary outcome
Incidence of DLTs (Dose-limiting Toxicity) in the Combined Dose Escalation Phase
Time frame: 28 days during the first 4-week cycle
Objective response rate (ORR)
Time frame: Up to 1 year
6 secondary outcomes
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
Number of participants with abnormality in vital signs
Time frame: 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
Number of participants with abnormality in clinical chemistry parameters
Time frame: 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
Number of participants with abnormality in ECG parameters
Time frame: up to 30 days after the last administration
Results and safety
The study was stopped early (reason given: company development strategy adjustment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Derived from this study: PubMed 40715048Yuan Y, Deng Y, Jin Y, Guo Z, Pan Y, Wang C, Wang Z, Hu Y, Hua D, Meng X, Zhang Z, Zhao M, Dong X, Huang D, Li X, Liu L, Sun M, Wang H, Wang X, Yang N, Zhang M, Hu S, Wu D, Huang J, Zhang S, Huang M, Ding K. Efficacy and safety of IBI351 (fulzerasib) monotherapy in KRASG12C inhibitor-naive Chinese patients with KRASG12C-mutated metastatic colorectal cancer: a pooled analysis from phase I part of two studies. Signal Transduct Target Ther. 2025 Jul 25;10(1):241. doi: 10.1038/s41392-025-02315-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBI351 and Cetuximab in people with Colorectal Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: company development strategy adjustment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DLTs (Dose-limiting Toxicity) in the Combined Dose Escalation Phase (time frame: 28 days during the first 4-week cycle). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05497336, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.