NCT04146181

Safety and Efficacy of SCT-I10A in Head and Neck Squamous Cell Carcinoma

A Phase II, Multicenter, Single-arm, Open-label Study of SCT-I10A in Patients With Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma Who Progressed on or After Platinum-based Chemotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (estimated)
• Sponsor: Sinocelltech Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy and safety of SCT-I10A for Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma who progressed on or after platinum-based chemotherapy

Detailed description

This is an open label, single-arm and multicenter phase II study designed to evaluate Objective Response Rate (ORR) of SCT-I10A for Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma who progressed on or after platinum-based chemotherapy.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	PD-1	SCT-I10A, 200 mg intravenous (IV) on Day 1 of each 3-week cycle.

Timeline

• Start date: 2019-10-31
• Primary completion: 2021-06-30
• Completion: 2021-09-30
• First posted: 2019-10-31
• Last updated: 2019-12-12

Locations

1 site across 1 country: China