By InvitationPhase 2

The Efficacy and Safety of IBI351, Cetuximab β Combined With FOLFIRI as First-line /IBI351, Cetuximab β as Second-line in the Treatment of KRAS G12C-mutated Metastatic Colorectal Cancer

China50 participantsStarted 2025-05-22

Plain-language summary

This is an open-label, multicenter, single-arm Phase II clinical study, divided into subgroups A and B: Cohort A - To evaluate the efficacy and safety of IBI351, cetuximab β combined with FOLFIRI as first-line treatment for metastatic colorectal cancer with KRAS G12C mutations; Twenty untreated patients with advanced colorectal cancer with KRAS G12C mutation are proposed to be enrolled and treated with the first-line IBI351+ cetuximab β injection +FOLFIRI regimen. The historical reference is expected to be around 40-50%, and it is expected to increase to around 75%. Therefore, among the 20 patients, if ≥15 patients achieve remission, it is considered that the efficacy of the trial protocol is statistically significant. Cohort B - To evaluate the efficacy and safety of BI351 and cetuximab β as second-line treatment for metastatic colorectal cancer with KRAS G12C mutations. It is proposed to enrolled 30 patients with advanced colorectal cancer with KRAS G12C mutation who have progressed after first-line treatment, and evaluate IBI351+ cetuximab β injection for second-line treatment. The historical reference is around 25%, and it is expected to increase to around 50%. Therefore, among the 30 patients, if ≥15 patients achieve remission, it is considered that the efficacy of the trial protocol is statistically significant. Imaging assessment of tumor remission was conducted every 8 weeks until disease progression. The period from the start of treatment to disease progression is defined as PFS. The safety observation indicators include: the incidence and severity of adverse events (AE) and serious adverse events (SAE); Laboratory tests, vital signs, physical examinations, and changes in electrocardiogram (ECG). Record the subsequent tumor treatment and survival follow-up after the progression. Definition of study conclusion: The study will conclude after the last subject has been treated for 2 years or has completed the treatment (whichever occurs first).

Who can participate

Age range18 Years – 75 Years

SexALL

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Exclusion criteria

✕. Inability to comply with the research protocol or research procedures.
✕. dMMR or MSI-H type colorectal cancer.
✕. Those who have been confirmed to be allergic to IBI 351, cetuximab β injection and/or its excipients.
✕. Have obvious cardiovascular system diseases, such as:
✕. Researchers identify patients with unstable brain metastases. For patients with brain metastases unintentionally detected during the screening process, if they do not cause clinical symptoms and do not require therapeutic intervention, they can be allowed to be enrolled. If the researchers determine that the brain metastasis is stably controlled, the hormone dose is used stably, and the prednisone dose is ≤10mg/d (if other steroid drugs are used, it is the corresponding equivalent dose), enrollment can be allowed.
✕. There are significant digestive tract diseases, such as intractable hiccups, nausea, vomiting, severe digestive tract ulcers, liver cirrhosis, active gastrointestinal bleeding, or other diseases that affect the swallowing of tablets or significantly affect the absorption of oral medications;
✕. There are major acute or chronic infections, including:
✕. Accompanied by pleural and peritoneal effusion or pericardial effusion that requires repeated drainage or has obvious symptoms.

What they're measuring

ORR

Timeframe: From enrollment to the end of treatment at 8 weeks

Trial details

NCT IDNCT06959589

SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-31

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