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

Sponsor
CSPC Megalith Biopharmaceutical Co.,Ltd.
Study ID
NCT07758621
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SYS6010 — DRUG
    SYS6010 by intravenous (IV)
  • Investigator's Choice of monotherapy — DRUG
    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）.

Study Details

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.

Key Dates

First listed
Aug 11, 2026
Start date
Aug 15, 2026
Status verified
Aug 2026
Primary completion
Sep 15, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
340 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SYS6010
    SYS6010 monotherapy
  • Active Comparator: Investigator's choice of monotherapy
    Investigator's choice of one of treatment (docetaxel,methotrexate, paclitaxel or cetuximab)

Primary Outcome Measure

Objective Response Rate (ORR) as assessed by IRC per RECIST v.1.1. [ Time Frame: Up to approximately 2 years ]

Central Contacts

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