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NOT YET RECRUITING
NCT07758621
PHASE3

SYS6010 vs Investigator's Choice of Monotherapy in Patients With Recurrent or Metastatic HNSCC

Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

View on ClinicalTrials.gov

Summary

This study is a randomized, controlled, open-label, multicenter phase III clinical trial, which aims to evaluate the efficacy, safety of SYS6010 compared with monotherapy in participants with HNSCC.

Official title: A Randomized, Controlled, Open-Label, Multicenter Phase 3 Trial Evaluating the Efficacy and Safety of SYS6010 Versus Investigator's Choice of Monotherapy in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

340

Start Date

2026-08-15

Completion Date

2028-12-01

Last Updated

2026-08-11

Healthy Volunteers

No

Interventions

DRUG

SYS6010

SYS6010 by intravenous (IV)

DRUG

Investigator's Choice of monotherapy

Investigator's choice of monotherapy means the therapy chosen by investigators to treat HNSCC including docetaxel (35 mg/m\^2 by IV on Day 1、8、15, every 28 days),methotrexate(40 mg/m\^2 by IV on Day 1、8、15, every 21 days), paclitaxel (80 mg/m\^2 by IV on Day 1、8、15, every 28 days) or cetuximab(400 mg/m\^2 by IV on C1D1, followed by 250 mg/m\^2 weekly).