Clinical trial · Interventional
Cetuximab in Refractory Colorectal Cancer With K-RAS Mutated and Favorable FcγRIIa (CD32) Genotype
Phase II Clinical Study of Cetuximab in Refractory Colorectal Cancer With K-RAS Mutated and Favourable FcγR IIa (CD32) Genotype
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This national, multicenter, open-label phase 2 study without any control arm aims to evaluate the activity of cetuximab monotherapy in the treatment of refractory colorectal cancer in subjects with K-RAS mutated and FcγRIIa polymorphism tumors, in which there is no therapeutic alternative for treatment. Failure of the first and second line conventional therapeutic lines was documented.
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 Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cetuximab
- interventionNames
- Drug: Cetuximab
Primary outcomes (1)
- measure
- Overall Survival (OS) Time
- timeFrame
- From the date of informed consent signature until death, assessed up to 3 years
- description
- Overall survival was defined as the time from date of informed consent signature until death.
Secondary outcomes (7)
- measure
- Percentage of Subjects With Disease Control Rate (DCR)
- timeFrame
- From the date of informed consent signature until progressive disease, assessed up to 3 years
- description
- DCR was defined as those subjects achieving complete response (CR), partial response (PR) or stable disease (SD), according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v.1.1). For target lesions (TLs), CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the sum of longest diameter (SLD) of the TLs, taking as a reference the baseline (BL) SLD; Stable disease (SD) was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For non-target lesions (NTLs), CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and progressive disease (PD) was defined as the appearance
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent form signed by the subject * Age greater than or equal to (\>=) 18 years * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (=\<) 2 * Life expectancy of greater than (\>) 2 months * Histological confirmed colorectal cancer (CRC) with mutated K-RAS and favorable genotypes (any H in FcγRIIa-131). Selection will be done only based on Cluster of differentiation (CD)32 polymorphisms * Epidermal growth factor receptor (EGFR) expression in his/her tumor sample * Stage 4 metastatic disease, with at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria, documented within 28 days prior to the study inclusion * Tumor tissue sample available for the assessment of K-RAS status and FcγRIIa (CD32) genotype * Subject who has received at least 2 prior therapeutic lines * Adequate bone marrow function, defined as: * haemoglobin \> 9.0 gram per deciliter (g/dL) * platelet count \>100\*10\^9 per liter * absolute neutrophil count (ANC) \>=1.5\*10\^9/Liter * Adequate hepatic and renal function, defined as: * Serum bilirubin =\<1.5 times the upper limit of normal (ULN) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\<2.5\*ULN in absence of liver metastasis and ALT and AST =\<5\*ULN in the presence of liver metastasis * Alkaline phosphatase =\<2.5\*ULN or =\<5 in the presence of liver metastasis or =\<10 in the absence of liver metastasis * Creatinine clearance \>= 50 milliliter per minute (mL/min) (according to Cockcroft and Gault formula) or serum creatinine \<1.5\*ULN * Adequate recovery after recent surgery, chemotherapy or radiotherapy. Prior major surgery, chemotherapy, treatment with an investigational product or radiotherapy must have occurred at least 4 weeks before study inclusion * Women of child-bearing potential must have a negative pregnancy test performed within 7 days prior to the study inclusion. Postmenopausal women must be amenorrheic for at least 12 months. If the risk of conception exists both male and female subjects must use effective contraception (for example, abstinence, intrauterine device (IUD), oral contraceptive, double barrier method or to be surgically sterile) since the signature of the consent form until at least 6 months after the end of treatment or end of last dose, whichever occurs first Exclusion Criteria: * Previous treatment with monoclonal antibodies against EGFR * Toxicity, due to previous treatment, not resolved to Grade 1 before the subject's inclusion into the study * Clinically relevant coronary disease or myocardial infarction, unstable angina, Grade \>=2 congestive cardiac insufficiency according to New York Heart Association (NYHA) within 6 months before starting the study treatment * Clinically significant vascular disease (for example, aortic aneurysm which requires surgery, pulmonary embolism, recent peripheral arterial thrombosis) within 12 months prior to starting the study treatment * Evidence of uncontrolled brain metastases * History of active neurological disease * History of uncontrolled seizures * History of lung fibrosis, acute pulmonary damage or interstitial pneumonia * Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C infection, or presence of severe, uncontrolled intercurrent infections or other severe uncontrolled concomitant diseases * Current Grade \>=2 (National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\]) infection * History of uncontrolled diabetes, uncontrolled hypertension or hepatic involvement * Known or suspected allergy or hypersensitivity to cetuximab * History of previous malignancy other than CRC occurring within 5 years before starting the study treatment, except for previously cured basal cell carcinoma of skin or carcinoma in situ of the cervix or urinary bladder treated more than 2 years before recruitment * Participation in another treatment study with an investigational drug within the last 30 days * Pregnancy or lactation * Any medical, psychological, psychiatric or social uncontrolled problem which may interfere in the participation of the subject in the study or in the evaluation of the study results * Psychological, familiar or geographic conditions not allowing the adequate follow-up and adherence to the study protocol
References
Publications (1)
- DERIVEDManzanares-Martin B, Cebrian Aranda A, Del Puerto-Nevado L, Gonzalez R, Solanes S, Gomez-Espana MA, Garcia-Foncillas J, Aranda E. Improving selection of patients with metastatic colorectal cancer to benefit from cetuximab based on KIR genotypes. J Immunother Cancer. 2021 Apr;9(4):e001705. doi: 10.1136/jitc-2020-001705. PMID 33833048