Spots Global Cancer Trial Database for KL-A167 Injection in Recurrent or Metastatic Nasopharyngeal Carcinoma
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Trial Identification
Brief Title: KL-A167 Injection in Recurrent or Metastatic Nasopharyngeal Carcinoma
Official Title: A Phase 2 Clinical Study To Evaluate the Efficacy and Safety of KL-A167 Injection in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
Study ID: NCT03848286
Interventions
Study Description
Brief 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
Detailed Description: KL167-Ⅱ-05-CTP (NCT03848286) is a single-arm, open-label, multicenter, phase II study of KL-A167 in pts with R/M NPC. Eligible pts were diagnosed with histopathologically confirmed R/M nonkeratinizing NPC and had received ≥ two lines of chemotherapy. Pts received 900 mg KL-A167 every 2 weeks until disease progression, intolerable toxicity, or withdrawal of consent. The primary endpoint was overall response rate (ORR) evaluated by the independent review committee (IRC) according to Response Evaluation Criteria in Solid Tumors Version 1.1.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China
Contact Details
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