NCT03848286

KL-A167 Injection in Recurrent or Metastatic Nasopharyngeal Carcinoma

A Phase 2 Clinical Study To Evaluate the Efficacy and Safety of KL-A167 Injection in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nasopharyngeal Carcinoma
• Recurrent or Metastatic

Interventions

Type	Name	Description
DRUG	KL-A167 Injection	KL-A167 900 mg intravenously (IV) every-2-weeks (Q2W)

Timeline

• Start date: 2019-03-06
• Primary completion: 2021-07-13
• Completion: 2022-01-13
• First posted: 2019-02-20
• Last updated: 2023-10-23

Locations

1 site across 1 country: China