KL-A167 Injection in Recurrent or Metastatic Nasopharyngeal Carcinoma (NCT03848286) | Clinical Trial Compass
CompletedPhase 2
KL-A167 Injection in Recurrent or Metastatic Nasopharyngeal Carcinoma
China153 participantsStarted 2019-03-06
Plain-language summary
The study is to evaluate the efficacy of KL-A167 injection in subjects with recurrent/metastatic Nasopharyngeal Carcinoma, as measured by Overall Response Rate (ORR) per the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged ≥ 18 years old, male or female;
* Subjects with histopathologically confirmed recurrent/metastatic nonkeratinizing differentiated or undifferentiated NPC;
* Subjects with diseases of clinical stage IVB \[Staging System of American Joint Committee on Cancer (AJCC) (8th edition)\] who have received first line of platinum-containing combination chemotherapy and second line of monotherapy or failure of combination therapy;
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
* Expected survival ≥ 12 weeks;
* Subjects with at least one measurable lesion according to RECIST 1.1, and lesions that have been treated with local therapies, such as radiotherapy, cannot be considered as measurable lesions;
* Tissue or tissue samples must be provided for biomarker analysis. Newly obtained tissues are preferred, and archived paraffin slices are acceptable for patients who do not have newly obtained tissues;
* Adequate organ and bone marrow function, as defined below: a) Hematology: neutrophil count (NEUT #) ≥ 1.5 × 10\^9/L; platelet count (PLT) ≥ 90 × 10\^9/L; hemoglobin concentration ≥ 9 g/dL; b) Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ 1.5 × ULN; ALT and AST ≤ 5 × ULN for subjects with liver metastases; TBIL ≤ 2 × ULN for subjects with liver metastases or Gilbert's syndrome; c) Renal function: creatinine clearance (CCR) ≥ 50 mL/min…
What they're measuring
1
Objective Response Rate (ORR) assess by Independent Review Committee (IRC)
Timeframe: from first patient first visit to 12 month after last patient first dose