MedTrace Logo

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

NCT07758621 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2026-08-11

No results posted yet for this study

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.

Conditions

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）.

Sponsors & Collaborators

  • CSPC Megalith Biopharmaceutical Co.,Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2028-09-15
Completion
2028-12-01

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07758621 on ClinicalTrials.gov