Health Condition 1: C00- Malignant neoplasm of lip
Conditions
Interventions
Intervention1: Biosimilar Cetuximab: Dosage: The initial dose is 400 mg per m2 to be administered as an IV infusion over a period
of 120 mins, subsequently Cetuximab shall be administered at a dose o
Sponsors
Enzene Biosciences Limited
Alkem Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of 18-65 years of age at the time of signing the ICF 2. Has life expectancy of at least 6 months from screening 3. Histologically confirmed diagnosis of SCCHN 4. Presence of locally advanced or recurrent locoregional or metastatic disease as per Tumor Node Metastasis staging at screening 5. Has at least 1 measurable target lesion (tumor/lymph node) as per RECIST version 1.1 at screening 6. Eastern cooperative oncology group (ECOG) status 0 to 2 at screening 7. Willing and able to comply with the protocol 8. Willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with Nasopharyngeal cancer 2. Patient who has received cetuximab or other EGFR targeting agent treatment (except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to screening) 3. Surgery (other than minor interventions like diagnostic biopsy or intravenous port implantation) or irradiation within 30 days before enrollment 4. Known sensitivity to any component of the investigational product (IP) and medication used in this study 5. Clinical evidence of brain metastasis or leptomeningeal involvement 6. History of Interstitial Lung Disease 7. History of severe (Grade 3 or 4) allergic or hypersensitivity reaction to therapeutic antibodies 8. Patient’s having the following laboratory results at screening a. Absolute neutrophil count (ANC) less than 1,500/mm3 b. Hemoglobin (Hb) less than 9 g/dL c. Total Leucocyte count less than 3000/mm3 d. Platelet count less than 100,000/mm3 e. Total bilirubin level more than 1.5 times the upper limit of the normal laboratory range (ULN) f. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) levels more than equal to 5 times ULN g. Serum Creatinine level more than 1.5 times ULN h. Abnormal serum electrolytes (not within normal limit) i. INR and aPTT (not within normal limit) 9. Patients suffering from acute or chronic infection(s) 10. Myocardial infarction within 6 months prior to screening 11. Symptomatic congestive heart failure (New York Heart Association [NYHA] Grade 3 or 4), unstable angina pectoris within 6 months prior to screening, significant cardiac arrhythmia, history of stroke or transient ischemic attack within 1 year prior to screening 12. Pre-existing grade 2 or greater motor or sensory neuropathy 13. Active hemoptysis (defined as bright red blood of ½ teaspoon or more in saliva) within 30 days prior to enrollment. 14. Patients with history of keratitis 15. Positive serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) at screening 16. Female patients of childbearing potential not willing to implement adequate non hormonal contraceptive measures during the study period 17. Patients who are pregnant or nursing 18. Has any concurrent disease or condition, which in the opinion of the investigator does not allow participation of the patient in this study 19. Has participated in any other clinical trial and received experimental medications within 4 weeks prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Treatment emergent adverse events (TEAEs) during the study 2. Alteration of the laboratory investigations during the studyTimepoint: From Baseline to Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Disease Control Rate: The efficacy endpoint of the study is to evaluate the disease control rate defined as proportion of patients achieving complete response [CR], or partial response [PR] and stable disease [SD] as per response evaluation criteria in solid tumors (RECIST) version 1.1 at the EOS. DCR will be assessed at end of study visit i.e. visit 14. 2. Overall Response Rate (ORR) defined as proportion of patients achieving complete response [CR] or partial response [PR] as per response evaluation criteria in solid tumors (RECIST) version 1.1 at end of study visit i.e. visit 14Timepoint: From Baseline to Week 12 | — |
Countries
India
Contacts
Public ContactDr Vinayaka Shahavi
Alkem Laboratories Limited
Outcome results
None listed