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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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