Clinical trial · Interventional
A Study of IBI351 in Combination With Cetuximab in Subjects With KRAS G12C Mutated Metastatic Colorectal Cancer
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
NCT05497336CI-TRIAL-00122748terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): company development strategy adjustment
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| IBI351 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IBI351+Cetuximab
- description
- IBI351 recommended dose+Cetuximab 500mg/m2 IV Q2W
- interventionNames
- Drug: IBI351
- Drug: Cetuximab
- type
- EXPERIMENTAL
- label
- IBI351
- description
- IBI351 recommended dose
- interventionNames
- Drug: IBI351
Primary outcomes (2)
- measure
- Incidence of DLTs (Dose-limiting Toxicity) in the Combined Dose Escalation Phase
- timeFrame
- 28 days during the first 4-week cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDYuan 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. PMID 40715048